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

RECRUITINGPHASE2

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

NCT05489211•AstraZeneca

View on ClinicalTrials.gov

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.

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).

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+3 more criteria

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
+21 more criteria

Locations (95)

Research Site

Los Angeles, California, United States

Research Site

San Diego, California, United States

Research Site

Santa Rosa, California, United States

Research Site

Muncie, Indiana, United States

Research Site

Kansas City, Kansas, United States

Research Site

Boston, Massachusetts, United States

Research Site

Boston, Massachusetts, United States

Research Site

Grand Rapids, Michigan, United States

Research Site

East Brunswick, New Jersey, United States

Research Site

Albuquerque, New Mexico, United States

Key Dates

Start Date

September 6, 2022

Primary Completion Date

October 1, 2027

Completion Date

October 1, 2027

Last Updated

March 19, 2026

Enrollment

454

ESTIMATED participants

Conditions

Endometrial CancerGastric CancerMetastatic Castration-resistant Prostate CancerOvarian CancerColorectal CancerUrothelial CancerBiliary Tract Cancer

Interventions

Datopotamab deruxtecan (Dato-DXd)

DRUG

Capecitabine

DRUG

5-Fluorouracil

DRUG

Volrustomig

DRUG

Carboplatin

DRUG

Bevacizumab

DRUG

Rilvegostomig

DRUG

Prednisone/ prednisolone

DRUG

Cisplatin

DRUG

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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