A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)

August 3, 2026 updated by: Daiichi Sankyo

A Phase 1B/2 Pan-Tumor, Open-Label Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)

This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; cutaneous melanoma; and neuroendocrine carcinoma (NEC).

Study Overview

Status

Recruiting

Conditions

Recurrent or Metastatic Solid Tumors

Intervention / Treatment

Drug: Ifinatamab deruxtecan

Detailed Description

This study will evaluate the efficacy and safety of I-DXd in participants with recurrent or metastatic solid tumors. The study will be divided into 3 parts: Stage 1, Stage 2 and an optional Stage 3. Each cohort starts with Stage 1 and may continue to Stage 2 if sufficient safety and efficacy data are observed. The EC cohort may proceed to an optional Stage 3 expansion based on the totality of available data.

The HCC Safety Run-In (Phase 1) will assess the safety and tolerability of I-DXd in participants with HCC.

Study Type

Interventional

Enrollment (Estimated)

680

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: (US) Daiichi Sankyo Contact for Clinical Trial Information
Phone Number: 9089926400
Email: CTRinfo@dsi.com

Study Contact Backup

Name: (Asia) Daiichi Sankyo Contact for Clinical Trial Information
Phone Number: +81-3-6225-1111 (M-F 9-5 JST
Email: dsclinicaltrial@daiichisankyo.co.jp

Study Locations

Argentina
- - Buenos Aires, Argentina, C1061ABD
    - Not yet recruiting
    - DIABAID
    - Contact:
      
      Principal Investigator
  - Ciudad Autonoma Buenos Aires, Argentina, 1019
    - Active, not recruiting
    - Centro Medico Austral
  - Ciudad Autonoma Buenos Aires, Argentina, C1113AAE
    - Recruiting
    - Centro de Investigaciones Medicas y Desarrollo LC SRL LC Investigacion
    - Contact:
      
      Principal Investigator
- Buenos Aires
  - Mar del Plata, Buenos Aires, Argentina, B7600FYK
    - Recruiting
    - Centro de Investigaciones Medicas Mar Del Plata
    - Contact:
      
      Principal Investigator
- Ciudad Autonoma Buenos Aires
  - Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, C1118AAT
    - Recruiting
    - Hospital Aleman
    - Contact:
      
      Principal Investigator
  - Caba, Ciudad Autonoma Buenos Aires, Argentina, C1419GEP
    - Recruiting
    - Hospital Sirio Libanes
    - Contact:
      
      Principal Investigator
Australia
- New South Wales
  - Blacktown, New South Wales, Australia, NSW 2148
    - Recruiting
    - Blacktown Hospital
    - Contact:
      
      Principal Investigator
  - Mount Kuring-Gai, New South Wales, Australia, 2080
    - Recruiting
    - St Vincent's Hospital Sydney
    - Contact:
      
      Principal Investigator
  - St Leonards, New South Wales, Australia, 2065
    - Recruiting
    - Genesiscare North Shore Oncology
    - Contact:
      
      Principal Investigator
- Queensland
  - Woolloongabba, Queensland, Australia, 4102
    - Recruiting
    - Princess Alexandra Hospital
    - Contact:
      
      Principal Investigator
- Western Australia
  - Subiaco, Western Australia, Australia, 6008
    - Recruiting
    - St John of God Subiaco Hospital
    - Contact:
      
      Principal Investigator
Belgium
- - Brussels, Belgium, 1200
    - Recruiting
    - Cliniques Universitaires Saint-Luc
    - Contact:
      
      Principal Investigator
  - Charleroi, Belgium, 6000
    - Recruiting
    - Grand Hospital de Charleroi
    - Contact:
      
      Principal Investigator
  - Ghent, Belgium, 9000
    - Not yet recruiting
    - Universitair Ziekenhuis Gent
    - Contact:
      
      Principal Investigator
  - Leuven, Belgium, 3000
    - Recruiting
    - UZ Leuven
    - Contact:
      
      Principal Investigator
  - Liège, Belgium, 4000
    - Not yet recruiting
    - Chu de Liăge
    - Contact:
      
      Principal Investigator
Brazil
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
    - Recruiting
    - Hospital De Clinicas De Porto Alegre
    - Contact:
      
      Principal Investigator
  - Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
    - Recruiting
    - Hospital Sao Lucas da Pucrs
    - Contact:
      
      Principal Investigator
- Santa Catarina
  - Florianópolis, Santa Catarina, Brazil, 88034-000
    - Recruiting
    - Cepon - Centro de Pesquisas Oncolăgicas de Santa Catarina
    - Contact:
      
      Principal Investigator
- São Paulo
  - Barretos, São Paulo, Brazil, 14784-400
    - Recruiting
    - Hospital de Câncer de Barretos - Fundação Pio XII
    - Contact:
      
      Principal Investigator
  - Jaú, São Paulo, Brazil, 17210-120
    - Recruiting
    - Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho
    - Contact:
      
      Principal Investigator
Chile
- - La Serena, Chile, 1720430
    - Not yet recruiting
    - IC La Serena Research
    - Contact:
      
      Principal Investigator
  - Temuco, Chile, 4800827
    - Not yet recruiting
    - James Lind Centro de Investigacion del Cancer
    - Contact:
      
      Principal Investigator
- Biobio
  - Concepción, Biobio, Chile, 4030000
    - Recruiting
    - Biocenter
    - Contact:
      
      Principal Investigator
- Santiago Metropolitan
  - Santiago, Santiago Metropolitan, Chile, 8320000
    - Recruiting
    - Centro Del Cancer UC
    - Contact:
      
      Principal Investigator
  - Santiago, Santiago Metropolitan, Chile, 8320000
    - Recruiting
    - Clinica Redsalud Vitacura
    - Contact:
      
      Principal Investigator
France
- - Besançon, France, 25000
    - Active, not recruiting
    - CHU Besançon - Hôpital Jean Minjoz
  - Toulouse, France, 31059
    - Not yet recruiting
    - Institut Claudius Regaud
    - Contact:
      
      Principal Investigator
- Cote dÝOr
  - Dijon, Cote dÝOr, France, 21000
    - Recruiting
    - Centre Georges Francois Leclerc
    - Contact:
      
      Principal Investigator
- Gironde
  - Bordeaux, Gironde, France, 33076
    - Recruiting
    - Institut Bergonie
    - Contact:
      
      Principal Investigator
  - Bordeaux, Gironde, France, 33075
    - Recruiting
    - Hopital Saint André
    - Contact:
      
      Principal Investigator
- Herault
  - Montpellier, Herault, France, 34298
    - Recruiting
    - Institut Regional du Cancer de Montpellier
    - Contact:
      
      Principal Investigator
- Ille Et Vilaine
  - Rennes, Ille Et Vilaine, France, 35042
    - Recruiting
    - CRLCC Eugene Marquis
    - Contact:
      
      Principal Investigator
- Loire Atlantique
  - Saint-Herblain, Loire Atlantique, France, 44800
    - Recruiting
    - ICO - Site René Gauducheau
    - Contact:
      
      Principal Investigator
- Paris
  - Paris, Paris, France, 75005
    - Recruiting
    - Institut Curie - Site de Paris
    - Contact:
      
      Principal Investigator
- Rhone
  - Lyon, Rhone, France, 69008
    - Recruiting
    - Centre Leon Berard
    - Contact:
      
      Principal Investigator
- Val De Marne
  - Villejuif, Val De Marne, France, 94805
    - Recruiting
    - GustaveRoussy DptPharmacie
    - Contact:
      
      Principal Investigator
Germany
- - Berlin, Germany, 12351
    - Recruiting
    - Vivantes Klinikum Neukoelln
    - Contact:
      
      Principal Investigator
  - Berlin, Germany, 13353
    - Recruiting
    - Charită - Campus Charită Mitte
    - Contact:
      
      Principal Investigator
- Baden-Wurttemberg
  - Heidelberg, Baden-Wurttemberg, Germany, 69120
    - Recruiting
    - Universitaetsklinikum Heidelberg
    - Contact:
      
      Principal Investigator
  - Heilbronn, Baden-Wurttemberg, Germany, 74078
    - Recruiting
    - SLK-Kliniken Heilbronn GmbH
    - Contact:
      
      Principal Investigator
- North Rhine-Westphalia
  - Münster, North Rhine-Westphalia, Germany, 48149
    - Recruiting
    - Universitätsklinikum Münster, Medizinische Klinik A
    - Contact:
      
      Principal Investigator
- Rhineland-Palatinate
  - Mainz, Rhineland-Palatinate, Germany, 55131
    - Recruiting
    - Univ der Johannes GutenbergU
    - Contact:
      
      Principal Investigator
- Saxony
  - Dresden, Saxony, Germany, 01067
    - Recruiting
    - Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt
    - Contact:
      
      Principal Investigator
  - Leipzig, Saxony, Germany, 04103
    - Recruiting
    - Universitäres Krebszentrum Leipzig UCCL, UKL AöR
    - Contact:
      
      Principal Investigator
Ireland
- - Cork, Ireland, T12DC4A
    - Not yet recruiting
    - Cork University Hospital
    - Contact:
      
      Principal Investigator
  - Dublin, Ireland, D07 R2WY
    - Recruiting
    - Mater Misericordiae University Hospital
    - Contact:
      
      Principal Investigator
  - Dublin, Ireland, D24 NR0A
    - Recruiting
    - Tallaght University Hospital
    - Contact:
      
      Principal Investigator
  - Galway, Ireland, H91YR71
    - Not yet recruiting
    - University Hospital Galway
    - Contact:
      
      Principal Investigator
- Dublin
  - Dublin, Dublin, Ireland, D04 T6F4
    - Recruiting
    - St Vincent's University Hospital
    - Contact:
      
      Principal Investigator
Italy
- - Candiolo, Italy, 10060
    - Recruiting
    - Fondazione del Piemonte per l'Oncologia IRCCS Candiolo
    - Contact:
      
      Principal Investigator
  - Milan, Italy, 20133
    - Recruiting
    - Fondazione IRCCS Istituto Nazionale dei Tumori
    - Contact:
      
      Principal Investigator
  - Milan, Italy, 20162
    - Recruiting
    - Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
    - Contact:
      
      Principal Investigator
  - Naples, Italy, 80131
    - Recruiting
    - Istituto Nazionale Tumori Fondazione G. Pascale
    - Contact:
      
      Principal Investigator
  - Rome, Italy, 00168
    - Recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    - Contact:
      
      Principal Investigator
  - Rozzano, Italy, 20089
    - Recruiting
    - Istituto Clinico Humanitas
    - Contact:
      
      Principal Investigator
Japan
- - Saitama, Japan, 362-0806
    - Recruiting
    - Saitama Cancer Center
    - Contact:
      
      Principal Investigator
- Aichi-ken
  - Nagoya, Aichi-ken, Japan, 464-8681
    - Recruiting
    - Aichi Cancer Center Hospital
    - Contact:
      
      Principal Investigator
- Chiba
  - Kashiwa, Chiba, Japan, 277-8577
    - Recruiting
    - National Cancer Center Hospital East
    - Contact:
      
      Principal Investigator
- Ehime
  - Matsuyama, Ehime, Japan, 791-0280
    - Recruiting
    - National Hospital Organization Shikoku Cancer Center
    - Contact:
      
      Principal Investigator
- Osaka
  - Ōsaka-sayama, Osaka, Japan, 589-8511
    - Recruiting
    - Kindai University Hospital
    - Contact:
      
      Principal Investigator
- Shizuoka
  - Nagaizumi-cho, Shizuoka, Japan, 411-8777
    - Recruiting
    - Shizuoka Cancer Center
    - Contact:
      
      Principal Investigator
- Tokyo
  - Chuo-ku, Tokyo, Japan, 104-0045
    - Recruiting
    - National Cancer Center Hospital
    - Contact:
      
      Principal Investigator
  - Koto-ku, Tokyo, Japan, 135-8550
    - Recruiting
    - The Cancer Institute Hospital of JFCR
    - Contact:
      
      Principal Investigator
Mexico
- - Mérida, Mexico, 97070
    - Active, not recruiting
    - Medical Care & Research SA de CV
  - Mérida, Mexico, 97134
    - Active, not recruiting
    - Centro de Atenciăn E Investigaciăn Clănica En Oncologăa
  - México, Mexico, 06100
    - Active, not recruiting
    - Cryptex Investigación Clínica S.A. de C.V.
Netherlands
- - Amsterdam, Netherlands, 1081 HV
    - Recruiting
    - Amsterdam UMC, Locatie VUMC
    - Contact:
      
      Principal Investigator
  - Groningen, Netherlands, 9713 GZ
    - Recruiting
    - Universitair Medisch Centrum Groningen
    - Contact:
      
      Principal Investigator
  - Nijmegen, Netherlands, 6525 GA
    - Recruiting
    - Radboudumc Nijmegen
    - Contact:
      
      Principal Investigator
  - Rotterdam, Netherlands, 3015 GD
    - Recruiting
    - Erasmus Medisch Centrum
    - Contact:
      
      Principal Investigator
  - Utrecht, Netherlands, 3584 CW
    - Recruiting
    - UMC Utrecht
    - Contact:
      
      Principal Investigator
Poland
- - Krakow, Poland, 30-688
    - Recruiting
    - SPZOZ Szpital Uniwer w Krakowie
    - Contact:
      
      Principal Investigator
  - Lodz, Poland, 90-302
    - Recruiting
    - Instytut Msf Sp. z o.o.
    - Contact:
      
      Principal Investigator
  - Rzeszów, Poland, 35-021
    - Recruiting
    - MRUK-MED i Spółka z ograniczoną odpowiedzialnością
    - Contact:
      
      Principal Investigator
  - Siedlce, Poland, 08-110
    - Recruiting
    - Mazowiecki Szpital Wojewodzki W Siedlcach Sp Z O O
    - Contact:
      
      Principal Investigator
  - Skorzewo, Poland, 60-185
    - Recruiting
    - Aidport sp z o.o.
    - Contact:
      
      Principal Investigator
Portugal
- - Lisbon, Portugal, 1400-038
    - Recruiting
    - Fundacao Champalimaud
    - Contact:
      
      Principal Investigator
  - Lisbon, Portugal, 1649-035
    - Recruiting
    - Centro Hospitalar Universitário de Lisboa Norte
    - Contact:
      
      Principal Investigator
  - Lisbon, Portugal, 1099-023
    - Recruiting
    - Instituto Portuguăs de Oncologia de Lisboa Francisco Gentil, Epe
    - Contact:
      
      Principal Investigator
  - Porto, Portugal, 4099-001
    - Recruiting
    - Centro Hospitalar Universitário de Santo António
    - Contact:
      
      Principal Investigator
  - Porto, Portugal, 4200-072
    - Recruiting
    - Inst Portude Onco do Porto
    - Contact:
      
      Principal Investigator
Spain
- - Barcelona, Spain, 08035
    - Recruiting
    - Hospital Universitari Vall d'Hebron
    - Contact:
      
      Principal Investigator
  - Barcelona, Spain, 08036
    - Recruiting
    - Hospital Clinic De Barcelona
    - Contact:
      
      Principal Investigator
  - Barcelona, Spain, 08908
    - Recruiting
    - ICO L'Hospitalet - Hospital Duran i Reynals
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28041
    - Recruiting
    - Hospital Universitario 12 de Octubre
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28046
    - Recruiting
    - Hospital Universitario La Paz
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28040
    - Recruiting
    - Hospital Clinico San Carlos
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28009
    - Recruiting
    - Hospital General Universitario Gregorio Marañon
    - Contact:
      
      Principal Investigator
  - Seville, Spain, 41009
    - Recruiting
    - Hospital Universitario Virgen Macarena
    - Contact:
      
      Principal Investigator
Taiwan
- - Taichung, Taiwan, 404327
    - Recruiting
    - China Medical University Hospital
    - Contact:
      
      Principal Investigator
  - Tainan, Taiwan, 70403
    - Recruiting
    - National Cheng Kung University Hospitalx
    - Contact:
      
      Principal Investigator
  - Taipei, Taiwan, 10002
    - Recruiting
    - National Taiwan University Hospital
    - Contact:
      
      Principal Investigator
  - Taipei, Taiwan, 11217
    - Recruiting
    - Taipei Veterans General Hospital
    - Contact:
      
      Principal Investigator
  - Taipei, Taiwan, 11490
    - Recruiting
    - Tri-Service General Hospital
    - Contact:
      
      Principal Investigator
  - Taipei, Taiwan, 11259
    - Recruiting
    - Koo Foundation Sun Yat-Sen Cancer Center
    - Contact:
      
      Principal Investigator
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06010
    - Recruiting
    - Gulhane Training and Research Hospital
    - Contact:
      
      Principal Investigator
  - Ankara, Turkey (Türkiye), 06560
    - Recruiting
    - Gazi University Medical Faculty
    - Contact:
      
      Principal Investigator
  - Ankara, Turkey (Türkiye), 6590
    - Not yet recruiting
    - Ankara University Cebeci Hospital
    - Contact:
      
      Principal Investigator
  - Ankara, Turkey (Türkiye), 06800
    - Recruiting
    - Ankara City Hospital
    - Contact:
      
      Principal Investigator
  - Izmir, Turkey (Türkiye), 35530
    - Not yet recruiting
    - Izmir Medicalpark Hospital
    - Contact:
      
      Principal Investigator
- Istanbul
  - Bağcılar, Istanbul, Turkey (Türkiye), 34214
    - Recruiting
    - Medipol Mega University Hospital
    - Contact:
      
      Principal Investigator
United States
- California
  - Los Angeles, California, United States, 90067
    - Active, not recruiting
    - Valkyrie Clinical Trials
  - Los Angeles, California, United States, 91204
    - Recruiting
    - Los Angeles Cancer Network
    - Contact:
      
      Principal Investigator
  - Whittier, California, United States, 90602
    - Recruiting
    - Pih Health Hematology Medical Oncology
    - Contact:
      
      Principal Investigator
- Illinois
  - Skokie, Illinois, United States, 60077
    - Recruiting
    - Orchard Healthcare Research Inc
    - Contact:
      
      Principal Investigator
- Minnesota
  - Minneapolis, Minnesota, United States, 55114
    - Recruiting
    - M Health Fairview University of Minnesota Medical Center
    - Contact:
      
      Principal Investigator
- New York
  - New York, New York, United States, 10016
    - Recruiting
    - NYU Langone Health
    - Contact:
      
      Principal Investigator
  - New York, New York, United States, 10029
    - Recruiting
    - Icahn School of Medicine at Mount Sinai PRIME
    - Contact:
      
      Principal Investigator
  - Westbury, New York, United States, 11590
    - Recruiting
    - Clinical Research Alliance, Inc
    - Contact:
      
      Principal Investigator
  - White Plains, New York, United States, 10601
    - Recruiting
    - White Plains Hospital
    - Contact:
      
      Principal Investigator
- Tennessee
  - Chattanooga, Tennessee, United States, 37403
    - Recruiting
    - Erlanger Health, Inc
    - Contact:
      
      Principal Investigator
  - Germantown, Tennessee, United States, 38138
    - Recruiting
    - The West Clinic
    - Contact:
      
      Principal Investigator
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - Scri Oncology Partners
- Texas
  - Amarillo, Texas, United States, 79124
    - Recruiting
    - Texas Oncology - West Texas
  - Dallas, Texas, United States, 75246
    - Recruiting
    - Texas Oncology, P.A.
  - Pearland, Texas, United States, 77584
    - Recruiting
    - Texas Oncology Gulf Coast
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Recruiting
    - Huntsman Cancer Institute, University of Utah
    - Contact:
      
      Principal Investigator
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Virginia Cancer Specialists
    - Contact:
      
      Principal Investigator
- Washington
  - Wenatchee, Washington, United States, 98801
    - Recruiting
    - Wenatchee Valley Hospital and Clinics
    - Contact:
      
      Principal Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Participants must meet all of the following criteria to be included in the study:

Common Inclusion Criteria for All Participants

Participants must consent to provide a pretreatment tumor sample which has not been previously irradiated. Fresh biopsies are strongly preferred, however, if a fresh pretreatment biopsy is not feasible or the procedure is unsuccessful, an appropriate archival sample must be provided. The most recent archival sample obtained up to 5 years prior to consent is acceptable.
Participants ages ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years).
At least 1 measurable lesion on computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as assessed by the investigator.
Documentation of radiological disease progression on or after the previous standard-of-care regimen. For NEC participants for which the standard therapy does not exist OR for which the standard therapy is not appropriate by the investigator: presence of advanced/metastatic disease without previous regimen is acceptable.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Additional Inclusion Criteria for EC Participants

Pathologically or cytologically documented EC of any histological carcinoma subtype or endometrial carcinosarcoma, irrespective of microsatellite instability or mismatch repair status.
Relapse or progression after a platinum-containing systemic treatment and an immune checkpoint inhibitor (ICI)-containing regimen (combined or sequential). Participants with actionable target tumor mutation should have been previously treated with targeted therapy, with a maximum of 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma. Neoadjuvant/adjuvant therapy may count as 1 line of therapy if the subject progressed within 6 months after completion of therapy.

Additional Inclusion Criteria for HNSCC Participants

Pathologically or cytologically documented unresectable or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx, excluding nasopharynx, nasal cavity and paranasal sinuses, and unknown primary.
Has disease progression after platinum-based and ICI treatment, whether administered in combination or separately. Participants with actionable target tumor mutation should have been previously treated with targeted therapy, with a maximum of 2 prior therapy lines for unresectable or metastatic HNSCC.
Participants without radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrating a greater than (>)90-degree abutment or encasement of a major blood vessel.
Participants with no prior history of Grade greater than or equal to (≥)3 bleeding as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 within 28 days prior to the start of study drug related to the current head and neck cancer may be included in the study.
Documented p16 status for oropharyngeal cancer (historical results are acceptable if available).

Additional Inclusion Criterion for PDAC Participants

1. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma that has relapsed or progressed after 1 prior line of gemcitabine-based systemic therapy in the locally advanced/metastatic setting or after 2 lines of therapy if the participant has actionable target tumor mutation and has been previously treated with targeted therapy.

a. No prior treatment with topoisomerase I inhibitors, such as irinotecan or topotecan.

Additional Inclusion Criteria for CRC Participants

Pathologically or cytologically documented unresectable or metastatic CRC with microsatellite stable status (MSS).
Relapse or progression after 1 prior line of systemic therapy including a fluoropyrimidine plus oxaliplatin with or without anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb) or anti-epidermal growth factor receptor mAb therapy, as clinically indicated, or relapse or progression after 2 lines of therapy if the subject has received targeted therapy.
Note: Prior adjuvant/neoadjuvant systemic cytotoxic chemotherapy will count as 1 line of prior systemic therapy if there is documented disease progression during therapy or within 6 months of chemotherapy completion.
No prior treatment with topoisomerase I inhibitors, such as irinotecan or topotecan.

Additional Inclusion Criteria for HCC Participants

Pathologically or cytologically documented unresectable or metastatic HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible) or noninvasive diagnosis of HCC as per the American Association for the Study of Liver Diseases (AASLD) criteria in participants with a confirmed diagnosis of cirrhosis.
Relapse or progression after 1 prior line of an ICI-containing regimen (combination or monotherapy) in the locally advanced/metastatic setting, or relapse or progression after 2 lines of therapy if the participant has an actionable target tumor mutation and has been treated with targeted therapy.
Barcelona Clinic Liver Cancer (BCLC) Stage B or C.
Liver function status should be Child-Pugh (CP) Class A.
Albumin-Bilirubin (ALBI) Grade 1 within 7 days prior to the first dose of study drug.
Participants with large esophageal varices at risk of bleeding must be treated with conventional medical intervention: beta blockers or endoscopic treatment.

Additional Inclusion Criteria for Ad-eso/GEJ/Gastric Participants

Pathologically or cytologically documented unresectable or metastatic Ad-eso/GEJ/Gastric that has relapsed or progressed after 1 prior line of systemic therapy in the locally advanced/metastatic setting.
a. Participants with PD-(L)1+ or MSI-H/dMMR should receive ICI treatment if ICIs are standard of care in the country, unless the participant is ineligible for ICI treatment.
If the participant has known history of HER2 positivity (defined by IHC 3+ or IHC 2+ and in situ hybridization [ISH] positive, as classified by American Society of Clinical Oncology - College of American Pathologists [ASCO CAP]) or actionable target, the participant must have been previously treated with a targeted therapy.

Additional Inclusion Criteria for UC Participants

Pathologically or cytologically documented unresectable or metastatic UC of the bladder, renal pelvis, ureter, or urethra. Participants with histological variants are allowed if urothelial histology is predominant. Small cell/neuroendocrine tumors are not allowed even if mixed histology.
Relapse or progression after at least 1 prior line of ICI-containing systemic therapy, and 1 prior line of systemic chemotherapy, given in combination with other anticancer therapy or separately, with a maximum of 3 prior therapy lines.
1. At least 1 line of therapy should include enfortumab vedotin in countries where enfortumab vedotin is approved and available.
2. Perioperative systemic therapies will be counted as 1 line of therapy.
3. To meet inclusion criteria requirement of prior ICI-containing therapy, use in the perioperative or metastatic setting will suffice.
4. Participants with actionable target tumor mutation should have been previously treated with targeted therapy.
5. The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy.

Additional Inclusion Criteria for CC Participants

Histologically confirmed unresectable or metastatic CC that was previously treated with ≥1 prior line of systemic therapy in the locally advanced or metastatic setting. Participants with actionable target tumor mutation should have been previously treated with targeted therapy.
Participants should receive prior anti-programmed death 1 (PD-1)//programmed death-ligand 1 (PD-L1) treatment and/or tisotumab vedotin if those are standard of care in the country, unless the participant is ineligible for these treatments.

Additional Inclusion Criteria for OVC Participants

Histologically confirmed high-grade serous OVC, high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer that was previously treated with at least 1 line of platinum-based therapy and bevacizumab unless the participant is ineligible for treatment with bevacizumab.
Participant is no longer considered eligible for platinum-based therapy per the investigator's opinion or has progressed less than 180 days after the last dose of platinum therapy.
Participant is not considered primary platinum refractory and has not progressed during platinum treatment or within 4 weeks after the completion of platinum treatment.
Participants with actionable target tumor mutation should have been previously treated with targeted therapy.

Additional Inclusion Criteria for BTC Participants

Pathologically or cytologically documented unresectable or metastatic BTC (intra- or extrahepatic cholangiocarcinoma or gallbladder carcinoma).
Relapse or progression after at least 1 prior line of systemic therapy, or 2 prior lines of systemic therapy if the participant has an actionable target and has received targeted therapy.
Histological subtypes other than ampullary cancer, small cell cancer, lymphoma, sarcoma, neuroendocrine tumors, mixed tumor histology, and/or mucinous cystic neoplasms (Please note that the histological subtypes listed here are not allowed.)

Additional Inclusion Criteria for HER2-Low BC Participants

Pathologically or cytologically documented unresectable or metastatic BC.
Low HER2 expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested), according to ASCO-CAP 2018 HER2 testing guidelines, based on most recent testing, regardless of hormonal status.
Progression on or after treatment with trastuzumab deruxtecan (T-DXd).
Relapse or progression after at least 2 and a maximum of 3 prior lines of systemic therapy. Participants with metastatic hormone receptor (HR)+ BC who have received endocrine-based therapy and have received at least 2 and a maximum of 3 prior lines of additional systemic therapy in the metastatic setting. Participants with actionable target tumor mutation should have been previously treated with targeted therapy.

Additional Inclusion Criteria for HER2 IHC 0 BC Participants

Pathologically or cytologically documented unresectable or metastatic BC.
Negative for HER2 expression, defined as IHC 0 (ISH- or untested) according to ASCO-CAP 2018 HER2 testing guidelines, based on the most recent testing, regardless of hormonal status.
Relapse or progression after at least 2 and a maximum of 3 prior lines of systemic therapy. Participants with metastatic HR+ BC who have received endocrine-based therapy and have received at least 2 and a maximum of 3 prior lines of additional systemic therapy in the metastatic setting. Participants with actionable target tumor mutation should have been previously treated with targeted therapy.

Additional Inclusion Criteria for Cutaneous (Acral and Non-acral) Melanoma Participants

Histologically or cytologically confirmed cutaneous (acral and non-acral) melanoma.
Disease progression while on or after having received treatment with ≥1 prior line of ICI based therapy. Prior anti-PD-(L)1 therapy in the adjuvant setting may be counted as 1 line if there is recurrence within 12 weeks of the last dose. If the subject had BRAF mutated melanoma or other actionable target tumor mutation, they must have had disease progression on targeted therapy as well.

Additional Inclusion Criteria for NEC Participants

Histologically or cytologically confirmed NEC types other than neuroendocrine prostate cancer (NEPC), small cell lung cancer (SCLC), and Merkel Cell Carcinoma, as defined by WHO 2022. Participants must meet at least 1 of the following criteria:
1. Disease that is relapsed/refractory to standard systemic therapy OR
2. Disease for which standard therapy does not exist OR
3. Disease for which standard therapy is not considered appropriate by the investigator.
Participants with mixed histology of large-cell neuroendocrine carcinoma (LCNEC) and SCLC are eligible if the neuroendocrine component predominates and represents at least 50% of the overall tumor tissue.

Exclusion Criteria:

Participants who meet any of the following criteria will be disqualified from entering the study:

Prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd.
Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., T-DXd) due to treatment-related toxicities.
Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
Inadequate treatment washout period before enrollment as specified in the protocol.
Any history of interstitial lung disease (ILD)/pneumonitis, current ILD, or suspicion of ILD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Endometrial Cancer (EC) Participants with recurrent or metastatic EC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 milligrams per kilogram (mg/kg), intravenous (IV) infusion.	Drug: Ifinatamab deruxtecan Intravenous administration Other Names: I-DXd
Experimental: Cohort 2: Head and Neck Squamous Cell Carcinoma (HNSCC) Participants with recurrent or metastatic HNSCC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.	Drug: Ifinatamab deruxtecan Intravenous administration Other Names: I-DXd
Experimental: Cohort 3: Pancreatic Ductal Adenocarcinoma (PDAC) Participants with recurrent or metastatic PDAC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.	Drug: Ifinatamab deruxtecan Intravenous administration Other Names: I-DXd
Experimental: Cohort 4: Colorectal Cancer (CRC) Participants with recurrent or metastatic CRC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.	Drug: Ifinatamab deruxtecan Intravenous administration Other Names: I-DXd
Experimental: Cohort 5: Hepatocellular Carcinoma (HCC) Participants with recurrent or metastatic HCC who were previously treated with 1 or more systemic therapy will receive I-DXd, at the determined dose.	Drug: Ifinatamab deruxtecan Intravenous administration Other Names: I-DXd
Experimental: Cohort 6: Adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric) Participants with recurrent or metastatic Ad-Eso/GEJ/gastric who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.	Drug: Ifinatamab deruxtecan Intravenous administration Other Names: I-DXd
Experimental: Cohort 7: Urothelial Carcinoma (UC) Participants with recurrent or metastatic UC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.	Drug: Ifinatamab deruxtecan Intravenous administration Other Names: I-DXd
Experimental: Cohort 8: Ovarian Cancer (OVC) Participants with recurrent or metastatic non-squamous OVC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.	Drug: Ifinatamab deruxtecan Intravenous administration Other Names: I-DXd
Experimental: Cohort 9: Cervical Cancer (CC) Participants with recurrent or metastatic CC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.	Drug: Ifinatamab deruxtecan Intravenous administration Other Names: I-DXd
Experimental: Cohort 10: Biliary Tract Cancer (BTC) Participants with recurrent or metastatic BTC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.	Drug: Ifinatamab deruxtecan Intravenous administration Other Names: I-DXd
Experimental: Cohort 11: Human epidermal growth factor 2 (HER2)-low breast cancer (BC) Participants with recurrent or metastatic human epidermal growth factor 2 (HER2)-low BC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.	Drug: Ifinatamab deruxtecan Intravenous administration Other Names: I-DXd
Experimental: Cohort 12: HER2 Immunohistochemistry (IHC) 0 BC Participants with recurrent or metastatic HER2 IHC 0 BC who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.	Drug: Ifinatamab deruxtecan Intravenous administration Other Names: I-DXd
Experimental: Cohort 13: Cutaneous Melanoma Participants with recurrent or metastatic cutaneous melanoma who were previously treated with 1 or more systemic therapy will receive I-DXd, 12 mg/kg, IV infusion.	Drug: Ifinatamab deruxtecan Intravenous administration Other Names: I-DXd
Experimental: Cohort 14: Neuroendocrine Carcinoma (NEC) Participants with recurrent or metastatic NEC who were previously treated with 1 or more systemic therapy or for whom the standard therapy is not considered appropriate by the investigator will receive I-DXd, 12 mg/kg, IV infusion.	Drug: Ifinatamab deruxtecan Intravenous administration Other Names: I-DXd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) as Assessed by Investigator Time Frame: From the time of the first dose of study drug until the date of documented disease progression, death, loss to follow-up, or withdrawal by the subject, whichever occurs first (up to approximately 60 months)	ORR is defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) as assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	From the time of the first dose of study drug until the date of documented disease progression, death, loss to follow-up, or withdrawal by the subject, whichever occurs first (up to approximately 60 months)
Number of Participants Reporting Dose-limiting Toxicities (DLTs) in the HCC Cohort Time Frame: Cycle 1 Day 1 to Cycle 1 Day 21	A DLT is defined as any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes that occurs during the DLT evaluation period (from C1D1 to the end of Cycle 1 in Safety Run-in) and is Grade 3 or above, according to NCI-CTCAE version 5.0, with the exceptions as noted in the protocol.	Cycle 1 Day 1 to Cycle 1 Day 21
Number of Participants Reporting TEAEs and Death in the HCC Cohort Time Frame: From date of signing the informed consent form up to 47 days after the last dose of study drug, up to approximately 60 months	An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those AEs with start or worsening after the first dose date of I-DXd and up to 40 (+7) days after the last dose date of study drug.	From date of signing the informed consent form up to 47 days after the last dose of study drug, up to approximately 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) Time Frame: From date of signing the informed consent form up to 47 days after the last dose of study drug, up to approximately 60 months	An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those AEs with start or worsening after the first dose date of I-DXd and up to 40 (+7) days after the last dose date of study drug. A serious AE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, or may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes noted. AESIs will also be assessed. AEs will be coded using MedDRA and will be graded using NCI-CTCAE v5.0.	From date of signing the informed consent form up to 47 days after the last dose of study drug, up to approximately 60 months
Duration of Response (DoR) Time Frame: From the time of the first dose of study drug until the date of documented disease progression, death, loss to follow-up, or withdrawal by the subject, whichever occurs first, up to approximately 60 months	DoR is defined as the time from the date of first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first, as assessed by the Investigator per RECIST v1.1, respectively. CR is defined as a disappearance of all target and non-target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	From the time of the first dose of study drug until the date of documented disease progression, death, loss to follow-up, or withdrawal by the subject, whichever occurs first, up to approximately 60 months
Progression-free Survival (PFS) Time Frame: From the time of the first dose of study drug until the date of documented disease progression, death, loss to follow-up, or withdrawal by the subject, whichever occurs first, up to approximately 60 months	PFS is defined as the time interval from the date of the first dose of study drug to the date of disease progression as assessed by the investigator per RECIST v1.1 or death from any cause.	From the time of the first dose of study drug until the date of documented disease progression, death, loss to follow-up, or withdrawal by the subject, whichever occurs first, up to approximately 60 months
Disease Control Rate (DCR) Time Frame: From the time of the first dose of study drug until the date of documented disease progression (by investigator), death, loss to follow-up, or withdrawal by the subject, whichever occurs first, up to approximately 60 months	DCR is defined as the percentage of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD) as assessed by the Investigator per RECIST v1.1, respectively. CR is defined as a disappearance of all target and non-target lesions, PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as at least a 20% increase in the sum of diameters of target lesions.	From the time of the first dose of study drug until the date of documented disease progression (by investigator), death, loss to follow-up, or withdrawal by the subject, whichever occurs first, up to approximately 60 months
Overall Survival (OS) Time Frame: From the date of the first dose of drug up to the date of death due to any cause, up to approximately 60 months	OS is defined as the time interval from the date of the first dose of study drug to the date of death from any cause.	From the date of the first dose of drug up to the date of death due to any cause, up to approximately 60 months
Pharmacokinetic Parameter Maximum Concentration (CMax) for I DXd, total anti-B7-H3 antibody, and DXd Time Frame: Cycles1 & 3 Day1:pre-dose,end of infusion(EOI),post-dose at 3 hours(hr),6 hr;24 hr,168 hr;336 hr;504 hr; Cycles 2, 4, and 5 Day 1:pre-dose and EOI;Cycle 7 and every 2 cycles thereafter up to end of study(EOS)(60 months):pre-dose(every cycle is 21 days)]	Plasma pharmacokinetic parameters will be estimated using noncompartmental methods.	Cycles1 & 3 Day1:pre-dose,end of infusion(EOI),post-dose at 3 hours(hr),6 hr;24 hr,168 hr;336 hr;504 hr; Cycles 2, 4, and 5 Day 1:pre-dose and EOI;Cycle 7 and every 2 cycles thereafter up to end of study(EOS)(60 months):pre-dose(every cycle is 21 days)]
Pharmacokinetic Parameter Time to Reach Maximum Plasma Concentration (TMax) for I DXd, total anti-B7-H3 antibody, and DXd Time Frame: Cycles 1 and 3 Day 1: pre-dose, EOI, 3 hr, 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: pre-dose and EOI; Cycle 7 and every 2 cycles thereafter up to EOS (60 months): pre-dose (every cycle is 21 days)]	Plasma pharmacokinetic parameters will be estimated using noncompartmental methods.	Cycles 1 and 3 Day 1: pre-dose, EOI, 3 hr, 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: pre-dose and EOI; Cycle 7 and every 2 cycles thereafter up to EOS (60 months): pre-dose (every cycle is 21 days)]
Pharmacokinetic Parameter Half-life (t1/2) for I DXd, total anti-B7-H3 antibody, and DXd Time Frame: Cycles 1 and 3 Day 1: pre-dose, EOI, 3 hr, 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: pre-dose and EOI; Cycle 7 and every 2 cycles thereafter up to EOS (60 months): pre-dose (every cycle is 21 days)]	Plasma pharmacokinetic parameters will be estimated using noncompartmental methods.	Cycles 1 and 3 Day 1: pre-dose, EOI, 3 hr, 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: pre-dose and EOI; Cycle 7 and every 2 cycles thereafter up to EOS (60 months): pre-dose (every cycle is 21 days)]
Pharmacokinetic Parameter Minimum Concentration (Ctrough) for I DXd, total anti-B7-H3 antibody, and DXd Time Frame: Cycles 1 and 3 Day 1: pre-dose, EOI, 3 hr, 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: pre-dose and EOI; Cycle 7 and every 2 cycles thereafter up to EOS (60 months): pre-dose (every cycle is 21 days)]	Plasma pharmacokinetic parameters will be estimated using noncompartmental methods.	Cycles 1 and 3 Day 1: pre-dose, EOI, 3 hr, 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: pre-dose and EOI; Cycle 7 and every 2 cycles thereafter up to EOS (60 months): pre-dose (every cycle is 21 days)]
Pharmacokinetic Parameter Area Under the Curve (AUC) for I DXd, total anti-B7-H3 antibody, and DXd Time Frame: Cycles 1 and 3 Day 1: pre-dose, EOI, 3 hr, 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: pre-dose and EOI; Cycle 7 and every 2 cycles thereafter up to EOS (60 months): pre-dose (every cycle is 21 days)]	Plasma pharmacokinetic parameters will be estimated using noncompartmental methods.	Cycles 1 and 3 Day 1: pre-dose, EOI, 3 hr, 6 hr; 24 hr, 168 hr; 336 hr; 504 hr; Cycles 2, 4, and 5 Day 1: pre-dose and EOI; Cycle 7 and every 2 cycles thereafter up to EOS (60 months): pre-dose (every cycle is 21 days)]
Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) Time Frame: Baseline up to 60 months	Anti-drug antibodies will be measured in plasma using a validated assay.	Baseline up to 60 months
Percentage of Participants Who Have Treatment-emergent ADA Time Frame: Baseline up to 60 months	Anti-drug antibodies will be measured in plasma using a validated assay.	Baseline up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2024

Primary Completion (Estimated)

July 25, 2028

Study Completion (Estimated)

July 25, 2028

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

DS7300-203
jRCT2031240016 (Other Identifier: jRCT)
2023-509632-26-00 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing Time Frame

Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)

A Phase 1B/2 Pan-Tumor, Open-Label Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product