A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

June 30, 2026 updated by: Seagen, a wholly owned subsidiary of Pfizer

A Phase 1b/2 Open-Label Study of Disitamab Vedotin in Combination With Other Anticancer Therapies in Solid Tumors

This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer.

Participants in this study must have breast cancer or gastric cancer. Participants must have tumors that have HER2 on them. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2.

This clinical trial uses an experimental drug called disitamab vedotin (DV). Disitamab vedotin is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them.

This clinical trial uses a drug called tucatinib, which has been approved to treat cancer in the United States and some other countries. This drug is sold under the brand name TUKYSA®.

This study will test how safe and how well DV with tucatinib works for participants with solid tumors. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical trial is to evaluate disitamab vedotin in combination with tucatinib in subjects with LA/metastatic breast cancer or gastric cancer/GEJC that express HER2. The study has a dose escalation phase evaluating disitamab vedotin plus tucatinib followed by a dose optimization phase. The 2 dose levels identified in the dose escalation phase will be assessed in the optimization phase for both safety and efficacy in HER2-expressing LA/mBC and LA/mGC/GEJC. Once the safety and efficacy profile of disitamab vedotin plus tucatinib has been established and a disitamab vedotin dose with the optimum benefit/risk ratio has been determined the disitamab vedotin plus tucatinib combination therapy will be evaluated in an expansion phase with 4 expansion cohorts in subjects with HER2-low LA/mGC/GEJC, HER2+ LA/mGC/GEJC, HER2-low LA/mBC, and HER2+ LA/mBC.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Australia
      • Frankston, Australia
        • Peninsula & South Eastern Hematology and Oncology Group (PASO)
      • Melbourne, Australia, 3000
        • Peter MacCallum Cancer Centre
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Peninsula & South Eastern Hematology and Oncology Group (PASO)
      • Frankston, Victoria, Australia, 3199
        • Slade Pharmacy Frankston
      • Mount Waverley, Victoria, Australia, 3149
        • Slade Health
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BC Cancer Kelowna.
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network - Princess Margaret Cancer Centre
  • Germany
      • Berlin, Germany, 12203
        • Charité Universitätsmedizin Berlin, Campus Benjamin Franklin (CBF)
      • Essen, Germany, 45147
        • Universitatsklinikum Essen
      • Heidelberg, Germany, 69120
        • Heidelberg University Hospital and German Cancer Research Center
  • Italy
      • Naples, Italy, 80131
        • A.O.U. Federico II- U.O.C. Diagnostica per lmmagini e Radioterapia
    • Campania
      • Naples, Campania, Italy, 80131
        • A.O.U. Federico II
      • Naples, Campania, Italy, 80131
        • Azienda Ospedaliera Universitaria (AOU) Federico II
      • Naples, Campania, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale.
    • Lombardy
      • Milan, Lombardy, Italy, 20141
        • Istituto Europeo di Oncologia
      • Milan, Lombardy, Italy, 20162
        • Niguarda Ca' Granda Hospital
    • Sicily
      • Misterbianco (CT), Sicily, Italy, 95045
        • Humanitas Istituto Clinico Catanese
    • Veneto
      • Verona, Veneto, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata di Verona.
  • Japan
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Tokyo, Japan, 142-8666
        • Showa Medical University Hospital
    • Tokyo
      • Koto-ku, Tokyo, Japan, 135-8550
        • Japanese Foundation for Cancer Research
      • Koto-ku, Tokyo, Japan, 135-8550
        • Cancer Institute Hospital of Jfcr
    • Tokyo-to
      • Shinagawa-ku, Tokyo-to, Japan, 142-8666
        • Showa University Hospital
  • South Korea
      • Cheongju-si, South Korea, 28644
        • Chungbuk National University Hospital
      • Incheon, South Korea, 21565
        • Gachon University Gil Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Suwon, South Korea, 16247
        • St. Vincent's Hospital, The Catholic University of Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
    • Other
      • Busan, Other, South Korea, 49201
        • Dong-A University Hospital
      • Goyang-si, Other, South Korea, 10408
        • National Cancer Center
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
        • Seoul National University Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d´Hebron
      • Barcelona, Spain, 08023
        • Quirén Salud Barcelona
      • Bilbao, Spain, 48013
        • Hospital Universitario de Basurto
      • Erandio Bizkaia, Spain, 48950
        • Grupo Hospitalario QuironSalud
      • Madrid, Spain, 28050
        • Farmacia-Ensayos. Planta S - Hospital Universitario HM Sanchinarro-CIOCC-START Madrid
      • Madrid, Spain, 28050
        • START Madrid-CIOCC_Hospital HM Sanchinarro
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spain, 46004
        • Ecg Medica Sl
    • Catalonia
      • L'Hospitalet de Llobregat, Catalonia, Spain, 8908
        • Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Tainan, Taiwan, 704017
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 100225
        • National Taiwan University Hospital
      • Taipei, Taiwan, 106
        • National Taiwan University Cancer Center
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
      • Taoyuan City, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust
      • London, United Kingdom, EC1M 6BQ
        • St Bartholomew's Hospital
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden Hospital
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust (RM)
      • Manchester, United Kingdom, M20 4GJ
        • The Christie NHS Foundation Trust
      • Sutton, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • University of Arizona Cancer Center - North Campus
      • Tucson, Arizona, United States, 85704
        • Banner-University Medical Center Tucson Campus
      • Tucson, Arizona, United States, 85719
        • Banner-University Medical Center Tucson Campus
      • Tucson, Arizona, United States, 85719
        • The University of Arizona Cancer Center-North Campus Pharmacy, Attn: Kelly Myrdal
      • Tucson, Arizona, United States, 85724
        • The University of Arizona Cancer Center-Main
    • California
      • Orange, California, United States, 92868
        • UC Irvine Medical Center
      • Orange, California, United States, 92868
        • UC Irvine Health - Chao Family Comprehensive Cancer Center
      • San Francisco, California, United States, 94158
        • University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
      • Santa Monica, California, United States, 90404
        • UCLA Hematology/Oncology - Parkside
      • Santa Monica, California, United States, 90404
        • UCLA Department of Medicine - Hematology & Oncology
    • Colorado
      • Grand Junction, Colorado, United States, 81505
        • Colorado West Healthcare System, dba Community Hospital
      • Grand Junction, Colorado, United States, 81505
        • Colorado West Healthcare, dba Grand Valley Oncology
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital
      • Danbury, Connecticut, United States, 06810
        • Praxair Cancer Center / Danbury Hospital
      • Norwalk, Connecticut, United States, 06856
        • The Whittingham Cancer Center / Norwalk Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown University Medical Center
      • Washington D.C., District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center - McKinley Campus
      • Tampa, Florida, United States, 33607
        • Moffitt Cancer Center - International Plaza
      • Tampa, Florida, United States, 33612
        • Moffitt McKinley Hospital
      • Wesley Chapel, Florida, United States, 33544
        • Moffitt Cancer Center at Wesley Chapel
    • Georgia
      • Athens, Georgia, United States, 30606
        • Georgia Cancer Specialists - Athens
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Atlanta, Georgia, United States, 30342
        • Atlanta Cancer Care - Atlanta
      • Atlanta, Georgia, United States, 30341
        • Georgia Cancer Specialists - Annex
      • Atlanta, Georgia, United States, 30342
        • Georgia Cancer Specialists-Northside
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital, Inc.- Central Research Department
      • Blairsville, Georgia, United States, 30512
        • Georgia Cancer Specialists - Blairsville
      • Canton, Georgia, United States, 30115
        • Georgia Cancer Specialists - Canton
      • Cumming, Georgia, United States, 30041
        • Atlanta Cancer Care - Cumming
      • Cumming, Georgia, United States, 30041
        • Georgia Cancer Specialists - Cumming
      • Decatur, Georgia, United States, 30033
        • Georgia Cancer Specialists - Decatur
      • Duluth, Georgia, United States, 30096
        • Suburban Hematology-Oncology Associates - Duluth
      • Lawrenceville, Georgia, United States, 30046
        • Suburban Hematology-Oncology Associates- Lawrenceville
      • Macon, Georgia, United States, 31217
        • Georgia Cancer Specialists - Macon
      • Marietta, Georgia, United States, 30060
        • Georgia Cancer Specialists - Marietta
    • Illinois
      • Shiloh, Illinois, United States, 62269
        • Siteman Cancer Center - Shiloh
      • Shiloh, Illinois, United States, 62269
        • Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital.
      • Newton, Massachusetts, United States, 02459
        • Dana Farber Cancer Institute- Chestnut Hill
    • Missouri
      • City of Saint Peters, Missouri, United States, 63376
        • Siteman Cancer Center - St Peters
      • Creve Coeur, Missouri, United States, 63141
        • Siteman Cancer Center - West County
      • Florissant, Missouri, United States, 63031
        • Siteman Cancer Center - North County
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Cancer Institute LLC
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital Investigational Pharmacy
      • St Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine - Siteman Cancer Center
      • St Louis, Missouri, United States, 63129
        • Siteman Cancer Center - South County
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Cancer Center - Basking Ridge
      • Basking Ridge, New Jersey, United States, 07920
        • MSK Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering - Monmouth
      • Middletown, New Jersey, United States, 07748
        • MSK Monmouth.
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering - Bergen
      • Montvale, New Jersey, United States, 07645
        • MSK Bergen.
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • San Juan Oncology Associates
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center - Commack
      • Commack, New York, United States, 11725
        • MSK Commack.
      • Harrison, New York, United States, 10604
        • MSK Westchester.
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering - Westchester
      • Long Island City, New York, United States, 11101
        • Investigational Drug Service
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center - Main Hospital
      • Uniondale, New York, United States, 11553
        • MSK Nassau.
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering- Nassau
    • Ohio
      • Columbus, Ohio, United States, 43219
        • Zangmeister Cancer Center
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Saint Francis Hospital / Bon Secours - South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute - Pharmacy
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology-Nashville/Sarah Cannon Research Institute
      • Nashville, Tennessee, United States, 37203
        • SCRI Oncology Partners
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Carbone Cancer Center / University of Wisconsin
      • Madison, Wisconsin, United States, 53718
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

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

No

Description

Inclusion Criteria:

General Inclusion Criteria

  • Measurable disease according to RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

Dose Escalation and Optimization Phase Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma or breast carcinoma
  • Locally-advanced, unresectable, or metastatic stage
  • Must have experienced disease progression on or after standard of care therapies or be intolerant of standard of care therapies.

Cohort A (HER2-Low Breast Cancer) Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of breast carcinoma
  • Locally-advanced, unresectable, or metastatic stage
  • HER2-low status determined by most recent local assessment (IHC 1+ or IHC 2+/ISH-negative)

  • Prior therapies requirements

    • No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC.
    • Participants with known BRCA mutation must have received a PARP-inhibitor where available and not medically contraindicated
    • Have progression on or after, or intolerant to, T-DXd, sacituzumab govitecan, or other topoisomerase I inhibitor therapies, if available as local standard of care therapy

    • Participants with HR+ tumors must have intolerance to endocrine therapy or endocrine therapy refractory disease:

      • Progressed on ≥2 lines of endocrine therapy for LA/mBC AND had received a CDK4/6 inhibitor in the adjuvant or metastatic setting OR
      • Progressed on 1 line of endocrine therapy for LA/mBC AND had a relapse while on adjuvant endocrine therapy after definitive surgery for primary tumor AND had received a CDK4/6 inhibitor in the adjuvant or advanced setting
    • Participants with HR negative, HER2-low and PD-L1-positive (CPS 10 or greater) tumors must have received pembrolizumab with chemotherapy if available as local standard of care therapy.
    • Participants with HR negative, HER2-low and PD-L1-positive (CPS 10 or greater) tumors must have received pembrolizumab (or other PD-(L)1 inhibitor) with chemotherapy if available as local standard of care therapy and not medically contraindicated.

Cohort B (HER2+ Breast Cancer) Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis breast carcinoma
  • Locally-advanced, unresectable, or metastatic stage
  • HER2+ status determined by most recent local assessment (IHC 3+ or IHC 2+/ISH+)

  • Participants must have:

    • Received prior trastuzumab, pertuzumab and a taxane if available as local standard of care therapy for advanced disease.
    • Have progression on or after, or intolerant to, T-DXd or other topoisomerase I inhibitor therapies
    • No more than 3 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mBC

Cohort C (HER2-Low Gastric or Gastroesophageal Junction Adenocarcinoma) Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
  • Locally-advanced, unresectable, or metastatic stage
  • HER2-low expression defined as IHC 1+ or IHC 2+/ISH-negative determined by most recent local assessment
  • Willing and able to provide archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks

  • Participants must have received:

    • Prior systemic therapy with platinum, fluorouracil, or taxane for locally advanced unresectable or metastatic disease
    • Progression within 6 months of last dose of (neo)adjuvant cytotoxic chemotherapy is considered as 1 line of systemic therapy for LA/mGC/GEJC
    • Prior anti-PD-(L)1 therapy is allowed
    • No more than 2 prior systemic cytotoxic chemotherapy regimens (including ADC) for LA/mGC/GEJC
  • Must not have received prior treatment with HER2 directed therapy

Cohort D (HER2+ LA/mGC/GEJC) Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
  • Locally-advanced, unresectable, or metastatic stage
  • HER2+ status determined by most recent local assessment (IHC 3+ or IHC 2+/ISH+)

  • Participants must have:

    • Received prior trastuzumab plus fluoropyrimidine and platinum containing chemotherapy if no contraindication.
    • Prior T-DXd treatment is allowed
    • Prior PD1 inhibitor therapy is allowed
    • No more than 2 prior systemic cytotoxic chemotherapy regimens (including ADCs) for LA/mGC/GEJC

Exclusion Criteria:

  • Known hypersensitivity to any excipient contained in the drug formulation of disitamab vedotin or tucatinib
  • Prior therapy with ADCs with MMAE payload
  • Prior therapy with tucatinib
  • Active CNS and/or leptomeningeal metastasis.
  • Participants who have received prior systemic anticancer treatment including investigational agents within 4 weeks prior to first dose of study treatment
  • History of other invasive malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
  • Unable to swallow oral tablets or capsules or any significant GI disease which would preclude the adequate oral absorption of medications

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: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation - Previously treated advanced GC/GEJC or breast cancer
disitamab vedotin + tucatinib
Drug: disitamab vedotin
Given into the vein (IV; intravenous)
Other Names:
  • RC48, RC48-ADC
Drug: tucatinib
300mg given twice daily by mouth (orally)
Other Names:
  • TUKYSA, ONT-380, ARRY-380
Experimental: Dose Optimization - HER2-low and HER2+ LA/mBC
disitamab vedotin + tucatinib
Drug: disitamab vedotin
Given into the vein (IV; intravenous)
Other Names:
  • RC48, RC48-ADC
Drug: tucatinib
300mg given twice daily by mouth (orally)
Other Names:
  • TUKYSA, ONT-380, ARRY-380
Experimental: Dose Optimization - HER2-low and HER2+ LA/mGC/GEJC
disitamab vedotin + tucatinib
Drug: disitamab vedotin
Given into the vein (IV; intravenous)
Other Names:
  • RC48, RC48-ADC
Drug: tucatinib
300mg given twice daily by mouth (orally)
Other Names:
  • TUKYSA, ONT-380, ARRY-380
Experimental: Dose Expansion - HER2-low LA/mBC
disitamab vedotin + tucatinib
Drug: disitamab vedotin
Given into the vein (IV; intravenous)
Other Names:
  • RC48, RC48-ADC
Drug: tucatinib
300mg given twice daily by mouth (orally)
Other Names:
  • TUKYSA, ONT-380, ARRY-380
Experimental: Dose Expansion - HER2+ LA/mBC
disitamab vedotin + tucatinib
Drug: disitamab vedotin
Given into the vein (IV; intravenous)
Other Names:
  • RC48, RC48-ADC
Drug: tucatinib
300mg given twice daily by mouth (orally)
Other Names:
  • TUKYSA, ONT-380, ARRY-380
Experimental: Dose Expansion - HER2-low LA/mGC/GEJC
disitamab vedotin + tucatinib
Drug: disitamab vedotin
Given into the vein (IV; intravenous)
Other Names:
  • RC48, RC48-ADC
Drug: tucatinib
300mg given twice daily by mouth (orally)
Other Names:
  • TUKYSA, ONT-380, ARRY-380
Experimental: Dose Expansion - HER2+ LA/mGC/GEJC
disitamab vedotin + tucatinib
Drug: disitamab vedotin
Given into the vein (IV; intravenous)
Other Names:
  • RC48, RC48-ADC
Drug: tucatinib
300mg given twice daily by mouth (orally)
Other Names:
  • TUKYSA, ONT-380, ARRY-380

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Through 30 days after the last study treatment; approximately 5 years
Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Through 30 days after the last study treatment; approximately 5 years
Number of participants with laboratory abnormalities
Time Frame: Through 30-37 days after the last study treatment: approximately 5 years
Through 30-37 days after the last study treatment: approximately 5 years
Number of participants with dose alterations
Time Frame: Through 30-37 days after the last study treatment: approximately 5 years
Through 30-37 days after the last study treatment: approximately 5 years
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
Time Frame: Approximately 3 years
The proportion of participants with confirmed response (CR) or partial response (PR) according to RECIST v1.1.
Approximately 3 years
Number of participants with dose limiting toxicities (DLTs) in dose escalation phase
Time Frame: Up to 28 days
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response (DOR) per RECIST v1.1 by investigator assessment
Time Frame: Approximately 5 years
The time from start of the first documentation of objective tumor response of CR or PR (that is subsequently confirmed) to the first documentation of progressive disease (PD) per RECIST v1.1, or to death due to any cause
Approximately 5 years
Disease control rate (DCR) per RECIST v1.1 by investigator assessment
Time Frame: Approximately 5 years
The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1.
Approximately 5 years
Pharmacokinetic (PK) parameter - Maximum concentration (Cmax)
Time Frame: Through 30-37 days after the last study treatment; approximately 5 years
Through 30-37 days after the last study treatment; approximately 5 years
PK parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)
Time Frame: Approximately 1 month
Approximately 1 month
Incidence of anti-drug antibodies (ADAs) against disitamab vedotin
Time Frame: Through 30-37 days after the last study treatment; approximately 5 years
Through 30-37 days after the last study treatment; approximately 5 years
Progression free survival (PFS) per RECIST v1.1 by investigator assessment
Time Frame: Approximately 5 years
The time from the start of any study treatment (or randomization date for participants in dose optimization phase) to the first documentation of disease progression per RECIST v1.1 or death due to any cause.
Approximately 5 years
Overall survival (OS)
Time Frame: Approximately 5 years
The time from the start of any study treatment (or randomization date for participants in dose optimization phase) to the date of death due to any cause.
Approximately 5 years

Collaborators and Investigators

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

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Collaborators

RemeGen Co., Ltd.

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

May 20, 2024

Primary Completion (Estimated)

July 28, 2029

Study Completion (Estimated)

July 28, 2029

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGNDV-004
  • C5731004 (Other Identifier: Alias Study Number)
  • 2023-507555-29-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
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