Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours

TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Colorectal Cancer; Ovarian Cancer; Endometrial Cancer; Urothelial Cancer; Biliary Tract Cancer; Metastatic Castration-resistant Prostate Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: Datopotamab deruxtecan (Dato-DXd); Drug: 5-Fluorouracil; Drug: Carboplatin; Drug: Bevacizumab; Drug: Volrustomig; Drug: Prednisone/ prednisolone; Drug: Rilvegostomig; Drug: Cisplatin

Detailed Description

This Phase II, open-label, uncontrolled, multicentre study evaluating the efficacy and safety of Dato-DXd as monotherapy (MONO) and in combination with anticancer agents (COMBO) in various advanced solid tumour types.

This study has a modular design, as such a master protocol with independent substudies enables simultaneous evaluation of the safety profile, recommended Phase II dose (RP2D), and efficacy of Dato-DXd in multiple disease populations and treatment combinations. This study will evaluate various solid tumour types, including endometrial cancer (Substudy 1), gastric cancer (Substudy 2), metastatic castration-resistant prostate cancer (mCRPC) (Substudy 3), ovarian cancer (Substudy 4), colorectal cancer (CRC) (Substudy 5), urothelial cancer (Substudy 6), and biliary tract cancer (Substudy 7) in the advanced or metastatic setting. Within each substudy, Dato-DXd will be evaluated as monotherapy (for all substudies except Substudy 2) and in combination with approved or novel anticancer agents that may be active in the tumour type being evaluated (for all substudies except Substudy 1 and Substudy 7).

• Study Type: Interventional
• Enrollment (Estimated): 454
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Research Site
    • Toronto, Ontario, Canada, M4N 3M5
      • Withdrawn
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • Research Site
    • Montreal, Quebec, Canada, H2X 0A9
      • Withdrawn
      • Research Site
    • Québec, Quebec, Canada, G1J 1Z4
      • Recruiting
      • Research Site
• China
  • Changsha, China, 410013
    • Withdrawn
    • Research Site
  • Chongqing, China, 400030
    • Withdrawn
    • Research Site
  • Guangzhou, China, 510060
    • Recruiting
    • Research Site
  • Guangzhou, China, 510120
    • Withdrawn
    • Research Site
  • Hangzhou, China, 310020
    • Recruiting
    • Research Site
  • Hefei, China, 230001
    • Withdrawn
    • Research Site
  • Shanghai, China, 200032
    • Recruiting
    • Research Site
  • Shanghai, China, 200032
    • Not yet recruiting
    • Research Site
  • Shenyang, China, 110016
    • Withdrawn
    • Research Site
  • Wuhan, China, 430030
    • Withdrawn
    • Research Site
  • Wuhan, China, 430079
    • Withdrawn
    • Research Site
  • Xi'an, China, 710000
    • Withdrawn
    • Research Site
  • Zhengzhou, China, 450052
    • Recruiting
    • Research Site
• France
  • Bordeaux, France, 33076
    • Recruiting
    • Research Site
  • Lyon, France, 69373
    • Recruiting
    • Research Site
  • Marseille, France, 13273
    • Withdrawn
    • Research Site
  • Suresnes, France, 92150
    • Recruiting
    • Research Site
• Germany
  • Berlin, Germany, 10117
    • Withdrawn
    • Research Site
  • Essen, Germany, 45136
    • Withdrawn
    • Research Site
  • Hanover, Germany, 30625
    • Withdrawn
    • Research Site
  • München, Germany, 81377
    • Withdrawn
    • Research Site
  • Regensburg, Germany, 93053
    • Withdrawn
    • Research Site
• Italy
  • Florence, Italy, 50139
    • Withdrawn
    • Research Site
  • Genova, Italy, 16132
    • Withdrawn
    • Research Site
  • Milan, Italy, 20132
    • Recruiting
    • Research Site
  • Milan, Italy, 20141
    • Withdrawn
    • Research Site
  • Milan, Italy, 20162
    • Recruiting
    • Research Site
  • Napoli, Italy, 80131
    • Recruiting
    • Research Site
  • Rome, Italy, 00168
    • Withdrawn
    • Research Site
• Japan
  • Chūōku, Japan, 104-0045
    • Recruiting
    • Research Site
  • Kashiwa, Japan, 277-8577
    • Recruiting
    • Research Site
  • Kōtoku, Japan, 135-8550
    • Recruiting
    • Research Site
  • Nagoya, Japan, 464-8681
    • Recruiting
    • Research Site
  • Shinagawa-ku, Japan, 142-8666
    • Recruiting
    • Research Site
  • Suita-shi, Japan, 565-0871
    • Recruiting
    • Research Site
• Poland
  • Gliwice, Poland, 44-102
    • Recruiting
    • Research Site
  • Krakow, Poland, 31-501
    • Recruiting
    • Research Site
  • Lodz, Poland, 92-213
    • Withdrawn
    • Research Site
  • Poznan, Poland, 61-866
    • Withdrawn
    • Research Site
  • Warsaw, Poland, 02-781
    • Recruiting
    • Research Site
• South Korea
  • Seoul, South Korea, 06351
    • Recruiting
    • Research Site
  • Seoul, South Korea, 05505
    • Recruiting
    • Research Site
  • Seoul, South Korea, 03722
    • Recruiting
    • Research Site
  • Seoul, South Korea, 110-744
    • Recruiting
    • Research Site
• Spain
  • Barcelona, Spain, 8035
    • Recruiting
    • Research Site
  • Córdoba, Spain, 14004
    • Terminated
    • Research Site
  • Madrid, Spain, 28046
    • Recruiting
    • Research Site
  • Málaga, Spain, 29010
    • Recruiting
    • Research Site
  • Pamplona, Spain, 31008
    • Recruiting
    • Research Site
  • Seville, Spain, 41013
    • Recruiting
    • Research Site
• Switzerland
  • Basel, Switzerland, 4031
    • Withdrawn
    • Research Site
  • Bellinzona, Switzerland, 6500
    • Withdrawn
    • Research Site
  • Sankt Gallen, Switzerland, 9007
    • Withdrawn
    • Research Site
• Taiwan
  • Liou Ying Township, Taiwan, 736
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 100
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 112
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 11259
    • Recruiting
    • Research Site
  • Taoyuan District, Taiwan, 333
    • Recruiting
    • Research Site
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06800
    • Recruiting
    • Research Site
  • Ankara, Turkey (Türkiye), 06620
    • Recruiting
    • Research Site
  • Cordaleo, Turkey (Türkiye), 35575
    • Recruiting
    • Research Site
  • Edirne, Turkey (Türkiye), 22030
    • Recruiting
    • Research Site
  • Kadıkoy/Istanbul, Turkey (Türkiye), 34722
    • Recruiting
    • Research Site
  • Konya, Turkey (Türkiye), 42080
    • Recruiting
    • Research Site
  • Pamukkale, Turkey (Türkiye), 20070
    • Recruiting
    • Research Site
  • Samsun, Turkey (Türkiye), 55139
    • Withdrawn
    • Research Site
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Research Site
  • Dundee, United Kingdom, DD1 9SY
    • Recruiting
    • Research Site
  • London, United Kingdom, EC1A 7BE
    • Recruiting
    • Research Site
  • London, United Kingdom, SE1 9RT
    • Recruiting
    • Research Site
  • London, United Kingdom, NW1 2PG
    • Recruiting
    • Research Site
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • Research Site
• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • Research Site
    • San Diego, California, United States, 92103
      • Withdrawn
      • Research Site
    • Santa Rosa, California, United States, 95403
      • Recruiting
      • Research Site
  • Indiana
    • Muncie, Indiana, United States, 47303
      • Withdrawn
      • Research Site
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Withdrawn
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Withdrawn
      • Research Site
    • Boston, Massachusetts, United States, 02215
      • Completed
      • Research Site
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Research Site
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Recruiting
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Recruiting
      • Research Site
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • Research Site
    • Columbus, Ohio, United States, 43219
      • Recruiting
      • Research Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Withdrawn
      • Research Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Research Site
    • Nashville, Tennessee, United States, 37232
      • Withdrawn
      • Research Site
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Research Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria: There are additional substudy requirements not reflected here. This list is based solely on the master CSP

• Male and female, ≥ 18 years
• Documented advanced or metastatic malignancy
• Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration over the 2 weeks prior to baseline or day of first dosing
• All participants must provide a tumour sample for tissue-based analysis
• At least 1 measurable lesion not previously irradiated, except Substudy 3 (Prostate Cancer) which allows participants with non measurable bone metastatic disease
• Adequate bone marrow reserve and organ function
• Minimum life expectancy of 12 weeks
• At the time of screening, contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• All women of childbearing potential must have a negative serum pregnancy test documented during screening
• Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control. Female participants must not donate, or retrieve for their own use, ova at any time during this study
• Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile, avoid intercourse, or use a highly effective method of contraception. Male participants must not freeze or donate sperm at any time during this study.
• Capable of giving signed informed consent
• Provision of signed and dated written optional genetic research informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative

Key Exclusion Criteria:

• Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol
• History of another primary malignancy except for adequately resected basal cell carcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancy treated with curative intent
• Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved
• Irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator, for example hearing loss
• Spinal cord compression or brain metastases unless treated
• Leptomeningeal carcinomatosis
• Clinically significant corneal disease
• Active hepatitis or uncontrolled hepatitis B or C virus infection
• Uncontrolled infection requiring IV antibiotics, antivirals or antifungals, for example prodromal symptoms
• Known HIV infection that is not well controlled
• Known active tuberculosis infection
• Mean resting corrected QTcF > 470 ms
• In the judgement of the investigator, history of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause TdP
• In the judgement of the investigator, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives
• Uncontrolled or significant cardiac diseases
• History of non-infectious Interstitial lung disease (ILD)/pneumonitis, including radiation pneumonitis that required steroids
• Has severe pulmonary function compromise
• Prior exposure to chloroquine/hydroxychloroquine without an adequate treatment washout period
• Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention
• Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment or any concurrent anticancer treatment
• Palliative radiotherapy with a limited field of radiation within ≤ 2 weeks or to more than 30% of the bone marrow within ≤ 4 weeks before the first dose of study intervention
• Major surgical procedure or significant traumatic injury within ≤ 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study
• Prior treatment with TROP2-directed therapies or other antibody-drug conjugate (ADCs) with deruxtecan payload
• Herbal or natural products intended as treatment or prophylaxis for any type of cancer that may interfere with the activity of the study intervention
• Previous treatment in the present study
• Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study
• Severe hypersensitivity to Dato-DXd or any of the excipients, including but not limited to polysorbate 80 or other monoclonal antibodies
• Involvement in the planning and/or conduct of the study
• Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements
• Females that are pregnant, breastfeeding, or planning to become pregnant
• Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of Dato-DXd

Study Plan

How is the study designed?

Design Details

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

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Substudy-1A; Dato-DXd will be evaluated as monotherapy	Drug: Datopotamab deruxtecan (Dato-DXd); Intravenous (IV) Antibody drug conjugate; Other Names: DS-1062a
Experimental: Substudy-2A; Dato-DXd in combination with capecitabine will be evaluated	Drug: Capecitabine; Administered orally; Other Names: Xeloda; Drug: Datopotamab deruxtecan (Dato-DXd); Intravenous (IV) Antibody drug conjugate; Other Names: DS-1062a
Experimental: Substudy-2B; Dato-DXd in combination with 5-FU will be evaluated	Drug: Datopotamab deruxtecan (Dato-DXd); Intravenous (IV) Antibody drug conjugate; Other Names: DS-1062a; Drug: 5-Fluorouracil; Administered as an IV; Other Names: Adrucil
Experimental: Substudy-3A; Dato-DXd will be evaluated as monotherapy	Drug: Datopotamab deruxtecan (Dato-DXd); Intravenous (IV) Antibody drug conjugate; Other Names: DS-1062a
Experimental: Substudy-5A; Dato-DXd will be evaluated as monotherapy	Drug: Datopotamab deruxtecan (Dato-DXd); Intravenous (IV) Antibody drug conjugate; Other Names: DS-1062a
Experimental: Substudy-3C; Dato-DXd will be evaluated in combination with prednisone/prednisolone	Drug: Datopotamab deruxtecan (Dato-DXd); Intravenous (IV) Antibody drug conjugate; Other Names: DS-1062a; Drug: Prednisone/ prednisolone; Administered orally; Other Names: Prednisolone
Experimental: Substudy-6B; Data-DXd in combination with rilvegostomig (AZD2936) will be evaluated	Drug: Datopotamab deruxtecan (Dato-DXd); Intravenous (IV) Antibody drug conjugate; Other Names: DS-1062a; Drug: Rilvegostomig; Administered as an IV; Other Names: AZD2936
Experimental: Substudy-4A; Dato-DXd will be evaluated as monotherapy	Drug: Datopotamab deruxtecan (Dato-DXd); Intravenous (IV) Antibody drug conjugate; Other Names: DS-1062a
Experimental: Substudy-4C; Dato-DXd in combination with carboplatin + bevacizumab followed by Dato-DXd + bevacizumab will be evaluated	Drug: Datopotamab deruxtecan (Dato-DXd); Intravenous (IV) Antibody drug conjugate; Other Names: DS-1062a; Drug: Carboplatin; Administered as an IV; Other Names: Paraplatin; Drug: Bevacizumab; Administered as an IV; Other Names: Avastin
Experimental: Substudy-6A; Dato-DXd in combination with volrustomig (MEDI5752) will be evaluated	Drug: Datopotamab deruxtecan (Dato-DXd); Intravenous (IV) Antibody drug conjugate; Other Names: DS-1062a; Drug: Volrustomig; Administered as an IV; Other Names: MEDI5752
Experimental: Substudy-6C; Dato-DXd will be evaluated as monotherapy	Drug: Datopotamab deruxtecan (Dato-DXd); Intravenous (IV) Antibody drug conjugate; Other Names: DS-1062a
Experimental: Substudy-6D; Dato-DXd in combination with carboplatin or cisplatin will be evaluated	Drug: Datopotamab deruxtecan (Dato-DXd); Intravenous (IV) Antibody drug conjugate; Other Names: DS-1062a; Drug: Carboplatin; Administered as an IV; Other Names: Paraplatin; Drug: Cisplatin; Administered as an IV; Other Names: Platinol
Experimental: Substudy-7A; Dato-DXd will be evaluated as monotherapy	Drug: Datopotamab deruxtecan (Dato-DXd); Intravenous (IV) Antibody drug conjugate; Other Names: DS-1062a
Experimental: Substudy-6E; Dato-DXd in combination with rilvegostomig (AZD2936) will be evaluated	Drug: Datopotamab deruxtecan (Dato-DXd); Intravenous (IV) Antibody drug conjugate; Other Names: DS-1062a; Drug: Rilvegostomig; Administered as an IV; Other Names: AZD2936

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1.	From baseline to progressive disease or death (approximately 1 year)
The number of subjects with adverse events/serious adverse events	Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.	Throughout the treatment and the safety follow-up period 28 [+ 7] days after the discontinuation of all study interventions, except durvalumab, nivolumab, and bevacizumab for which it will be 90 [+ 7] days (approximately 1 year)
Progression free survival (PFS) response (Substudy 4C only)	PFS is defined as time from start of treatment until progression per RECIST 1.1 as assessed by the investigator or death due to any cause.	From baseline to progressive disease or death (approximately 1 year)
PSA50 response (Substudy 3 only)	Proportion of participants achieving a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later.	From baseline to PSA response evaluated according to the PCWG3 criteria (approximately 1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best percentage change in tumour size	The best percentage change from baseline in tumour size will be derived as the maximum reduction from baseline or (in the absence of reduction) the minimum increase from baseline.	From baseline to progressive disease or death (approximately 1 year)
Plasma concentration of Total anti-TROP2 antibody	Expression of TROP2 will be measured in blood sample	Throughout the treatment period at pre-defined intervals (approximately 1 year)
Plasma concentration of MAAA-1181a	The concentration in plasma will be determined (Cmax will be derived).	Throughout the treatment period at pre-defined intervals (approximately 1 year)
Progression free survival (PFS)	PFS is defined as time from start of treatment until progression per RECIST 1.1 as assessed by the investigator or death due to any cause.	From baseline to progressive disease or death (approximately 1 year)
Pharmacokinetics of Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6): Maximum plasma concentration of the drug (Cmax)	The concentration in plasma will be determined.	At predefined intervals throughout the treatment period (approximately 1 year)
Pharmacokinetics of Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6): The time taken to reach the maximum concentration (Tmax)	The concentration in plasma will be determined.	At predefined intervals throughout the treatment period (approximately 1 year)
Pharmacokinetic Parameter of Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6): Area under the plasma concentration- time curve (AUC)	The concentration in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.	At predefined intervals throughout the treatment period (approximately 1 year)
Anti Drug Antibody (ADA) for Dato-DXd (all substudies) and volrustomig and rilvegostomig (substudy 6)	Whole blood samples for determination of ADA in plasma will be collected; Percentage of patients who develop ADA	Throughout the treatment period at pre-defined intervals and including the safety follow-up period (approximately 1 year)
Duration Of Response (DoR)	DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 as assessed by the investigator or death due to any cause.	From baseline to progressive disease or death (approximately 1 year)
Disease Control Rate (DCR)	DCR at 12 and 24 weeks is defined as the percentage of participants who prior to Progression of Disease (PD) and starting anticancer therapy have either at least one visit response of Complete response (CR)/Partial response (PR) or Stable disease (SD) for at least 11 and 23 weeks after the date of first dose respectively, per RECIST 1.1 as assessed by the investigator at local site and derived from the raw tumour data.	At approximately 1 year
Radiographic PFS (Substudy 3)	PFS is defined as time from start of treatment until radiographic progression per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone) as assessed by the investigator or death due to any cause.	From baseline to radiographic progression or death (approximately 1 year)
PSA progression (Substudy 3)	PSA progression is defined as an increase in PSA (after Week 12) of ≥25% greater than the nadir and an absolute increase of at least 2 ng/mL above nadir.	From baseline to PSA response evaluated according to the PCWG3 criteria (approximately 1 year)
CA-125 response (Substudy 4)	Proportion of participants achieving a > 50% reduction in CA-125 levels from a pre-treatment sample confirmed and maintained for at least 28 days.	From baseline to CA-125 response evaluated according to the GCIG criteria (approximately 1 year)
Overall survival (OS) (Substudy 4)	OS is defined as time from start of treatment until death due to any cause.	From baseline to death (approximately 1 year)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Daiichi Sankyo
• Investigators: Principal Investigator: Global Clinical Lead, MD, AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Solid Tumours; Datopotamab Deruxtecan (Dato-DXd); TROPION-PanTumor03; Antibody-drug conjugate (ADC); Trophoblast cell surface protein 2 (TROP2)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Rectal Diseases; Uterine Diseases; Genital Diseases, Female; Endocrine Gland Neoplasms; Biliary Tract Diseases; Colonic Diseases; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Uterine Neoplasms; Stomach Neoplasms; Biliary Tract Neoplasms; Colorectal Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Polycyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Nucleosides; Uracil; Pyrimidinones; Pregnadienetriols; Pregnadienediols; Platinum Compounds; Deoxyribonucleosides; Capecitabine; Bevacizumab; Prednisone; Prednisolone; Fluorouracil; Carboplatin; Cisplatin
• Other Study ID Numbers: D926UC00001; 2022-000776-19 (EudraCT Number); 2023-509436-26-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No