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
3 other identifiers
interventional
454
14 countries
95
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2022
Longer than P75 for phase_2
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2022
CompletedFirst Posted
Study publicly available on registry
August 5, 2022
CompletedStudy Start
First participant enrolled
September 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
March 19, 2026
March 1, 2026
5.1 years
July 21, 2022
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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)
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)
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)
Secondary Outcomes (14)
Progression free survival (PFS)
From baseline to progressive disease or death (approximately 1 year)
Duration Of Response (DoR)
From baseline to progressive disease or death (approximately 1 year)
Disease Control Rate (DCR)
At approximately 1 year
Best percentage change in tumour size
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)
At predefined intervals throughout the treatment period (approximately 1 year)
- +9 more secondary outcomes
Study Arms (14)
Substudy-1A
EXPERIMENTALDato-DXd will be evaluated as monotherapy
Substudy-2A
EXPERIMENTALDato-DXd in combination with capecitabine will be evaluated
Substudy-2B
EXPERIMENTALDato-DXd in combination with 5-FU will be evaluated
Substudy-3A
EXPERIMENTALDato-DXd will be evaluated as monotherapy
Substudy-3C
EXPERIMENTALDato-DXd will be evaluated in combination with prednisone/prednisolone
Substudy-4A
EXPERIMENTALDato-DXd will be evaluated as monotherapy
Substudy-4C
EXPERIMENTALDato-DXd in combination with carboplatin + bevacizumab followed by Dato-DXd + bevacizumab will be evaluated
Substudy-5A
EXPERIMENTALDato-DXd will be evaluated as monotherapy
Substudy-6A
EXPERIMENTALDato-DXd in combination with volrustomig (MEDI5752) will be evaluated
Substudy-6B
EXPERIMENTALData-DXd in combination with rilvegostomig (AZD2936) will be evaluated
Substudy-6C
EXPERIMENTALDato-DXd will be evaluated as monotherapy
Substudy-6D
EXPERIMENTALDato-DXd in combination with carboplatin or cisplatin will be evaluated
Substudy-6E
EXPERIMENTALDato-DXd in combination with rilvegostomig (AZD2936) will be evaluated
Substudy-7A
EXPERIMENTALDato-DXd will be evaluated as monotherapy
Interventions
Intravenous (IV) Antibody drug conjugate
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Daiichi Sankyocollaborator
Study Sites (95)
Research Site
Los Angeles, California, 90095, United States
Research Site
San Diego, California, 92103, United States
Research Site
Santa Rosa, California, 95403, United States
Research Site
Muncie, Indiana, 47303, United States
Research Site
Kansas City, Kansas, 66160, United States
Research Site
Boston, Massachusetts, 02114, United States
Research Site
Boston, Massachusetts, 02215, United States
Research Site
Grand Rapids, Michigan, 49503, United States
Research Site
East Brunswick, New Jersey, 08816, United States
Research Site
Albuquerque, New Mexico, 87109, United States
Research Site
Commack, New York, 11725, United States
Research Site
Cincinnati, Ohio, 45219, United States
Research Site
Columbus, Ohio, 43219, United States
Research Site
Portland, Oregon, 97239, United States
Research Site
Nashville, Tennessee, 37203, United States
Research Site
Nashville, Tennessee, 37232, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Madison, Wisconsin, 53792, United States
Research Site
Toronto, Ontario, M4N 3M5, Canada
Research Site
Toronto, Ontario, M5G 2M9, Canada
Research Site
Montreal, Quebec, H2X 0A9, Canada
Research Site
Montreal, Quebec, H4A 3J1, Canada
Research Site
Québec, Quebec, G1J 1Z4, Canada
Research Site
Changsha, 410013, China
Research Site
Chongqing, 400030, China
Research Site
Guangzhou, 510060, China
Research Site
Guangzhou, 510120, China
Research Site
Hangzhou, 310020, China
Research Site
Hefei, 230001, China
Research Site
Shanghai, 200032, China
Research Site
Shanghai, 200032, China
Research Site
Shenyang, 110016, China
Research Site
Wuhan, 430030, China
Research Site
Wuhan, 430079, China
Research Site
Xi'an, 710000, China
Research Site
Zhengzhou, 450052, China
Research Site
Bordeaux, 33076, France
Research Site
Lyon, 69373, France
Research Site
Marseille, 13273, France
Research Site
Suresnes, 92150, France
Research Site
Berlin, 10117, Germany
Research Site
Essen, 45136, Germany
Research Site
Hanover, 30625, Germany
Research Site
München, 81377, Germany
Research Site
Regensburg, 93053, Germany
Research Site
Florence, 50139, Italy
Research Site
Genova, 16132, Italy
Research Site
Milan, 20132, Italy
Research Site
Milan, 20141, Italy
Research Site
Milan, 20162, Italy
Research Site
Naples, 80131, Italy
Research Site
Rome, 00168, Italy
Research Site
Chūōku, 104-0045, Japan
Research Site
Kashiwa, 277-8577, Japan
Research Site
Kōtoku, 135-8550, Japan
Research Site
Nagoya, 464-8681, Japan
Research Site
Shinagawa-ku, 142-8666, Japan
Research Site
Suita-shi, 565-0871, Japan
Research Site
Gliwice, 44-102, Poland
Research Site
Krakow, 31-501, Poland
Research Site
Lodz, 92-213, Poland
Research Site
Poznan, 61-866, Poland
Research Site
Warsaw, 02-781, Poland
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Seoul, 110-744, South Korea
Research Site
Barcelona, 8035, Spain
Research Site
Córdoba, 14004, Spain
Research Site
Madrid, 28046, Spain
Research Site
Málaga, 29010, Spain
Research Site
Pamplona, 31008, Spain
Research Site
Seville, 41013, Spain
Research Site
Basel, 4031, Switzerland
Research Site
Bellinzona, 6500, Switzerland
Research Site
Sankt Gallen, 9007, Switzerland
Research Site
Liou Ying Township, 736, Taiwan
Research Site
Taipei, 100, Taiwan
Research Site
Taipei, 11259, Taiwan
Research Site
Taipei, 112, Taiwan
Research Site
Taoyuan District, 333, Taiwan
Research Site
Ankara, 06620, Turkey (Türkiye)
Research Site
Ankara, 06800, Turkey (Türkiye)
Research Site
Cordaleo, 35575, Turkey (Türkiye)
Research Site
Edirne, 22030, Turkey (Türkiye)
Research Site
Kadıkoy/Istanbul, 34722, Turkey (Türkiye)
Research Site
Konya, 42080, Turkey (Türkiye)
Research Site
Pamukkale, 20070, Turkey (Türkiye)
Research Site
Samsun, 55139, Turkey (Türkiye)
Research Site
Cambridge, CB2 0QQ, United Kingdom
Research Site
Dundee, DD1 9SY, United Kingdom
Research Site
London, EC1A 7BE, United Kingdom
Research Site
London, NW1 2PG, United Kingdom
Research Site
London, SE1 9RT, United Kingdom
Research Site
Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Global Clinical Lead, MD
AstraZeneca
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- The study is open label. Patients will be assigned treatment in all Substudies.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2022
First Posted
August 5, 2022
Study Start
September 6, 2022
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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
- 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.
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.