NCT05489211

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 454 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Endometrial Cancer
• Gastric Cancer
• Metastatic Castration-resistant Prostate Cancer
• Ovarian Cancer
• Colorectal Cancer
• Urothelial Cancer
• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Datopotamab deruxtecan (Dato-DXd)	Intravenous (IV) Antibody drug conjugate
DRUG	Capecitabine	Administered orally
DRUG	5-Fluorouracil	Administered as an IV
DRUG	Volrustomig	Administered as an IV
DRUG	Carboplatin	Administered as an IV
DRUG	Bevacizumab	Administered as an IV
DRUG	Rilvegostomig	Administered as an IV
DRUG	Prednisone/ prednisolone	Administered orally
DRUG	Cisplatin	Administered as an IV

Timeline

• Start date: 2022-09-06
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2022-08-05
• Last updated: 2026-03-19

Locations

95 sites across 14 countries: United States, Canada, China, France, Germany, Italy, Japan, Poland, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study