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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509436-26-00

Acronym

D926UC00001

Enrollment

177

Registered

2024-06-24

Start date

2022-12-05

Completion date

Unknown

Last updated

2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

Objective response rate (ORR), AEs/SAEs, ECOG performance status, changes from baseline in laboratory findings,ECGs, vital signs, physical examinations, and ophthalmologic assessments, PSA50 response (Substudy 3: Castration-resistant Prostate Cancer), Progression-free survival (PFS) (Substudy 4: Ovarian Cancer)

Detailed description

Progression-free survival (PFS), Duration of response (DoR), Disease control rate (DCR), Best percentage change in tumour size, Plasma concentrations and PK parameters, total anti-TROP2 antibody, and MAAA-1181a, Serum concentration of volrustomig and rilvegostomig (Substudy 6), Presence of ADAs for Dato-DXd (all Substudies), volrustomig and rilvegostomig (Substudy 6), Radiographic Progression-free survival (rPFS) (Substudy 3), Time to PSA progression (Substudy 3), CA-125 response (Substudy 4), OS (Overall survival) (Substudy 4)

Interventions

DRUGMYCOPHENOLATE MOFETIL

DRUGCAPECITABINE

DRUGCARBOPLATIN

DRUGCISPLATIN

DRUGINFLIXIMAB

DRUGFLUOROURACIL

DRUGvolrustomig

DRUGRilvegostomig

DRUGCALCIUM FOLINATE

DRUGBEVACIZUMAB

DRUGPREDNISOLONE

DRUGDatopotamab deruxtecan

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR), AEs/SAEs, ECOG performance status, changes from baseline in laboratory findings,ECGs, vital signs, physical examinations, and ophthalmologic assessments, PSA50 response (Substudy 3: Castration-resistant Prostate Cancer), Progression-free survival (PFS) (Substudy 4: Ovarian Cancer)	—

Secondary

Measure	Time frame
Progression-free survival (PFS), Duration of response (DoR), Disease control rate (DCR), Best percentage change in tumour size, Plasma concentrations and PK parameters, total anti-TROP2 antibody, and MAAA-1181a, Serum concentration of volrustomig and rilvegostomig (Substudy 6), Presence of ADAs for Dato-DXd (all Substudies), volrustomig and rilvegostomig (Substudy 6), Radiographic Progression-free survival (rPFS) (Substudy 3), Time to PSA progression (Substudy 3), CA-125 response (Substudy 4), OS (Overall survival) (Substudy 4)	—

Measure

Time frame

—

Countries

France, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026