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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)

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NCT05489211 · readout in 407 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Daiichi Sankyo.

Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
454estimated
Sites
96
Countries
Canada, China, France +11

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2022-09-06actualWhen the study began enrolling
Primary completion2027-10-01estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2027-10-01estimatedThe whole study's end, after follow-up
First posted2022-08-05actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-13actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

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

Interventions

  • Drug: Datopotamab deruxtecan (Dato-DXd) — also filed as DS-1062a
  • Drug: Capecitabine — also filed as Xeloda
  • Drug: 5-Fluorouracil — also filed as Adrucil
  • Drug: Volrustomig — also filed as MEDI5752
  • Drug: Carboplatin — also filed as Paraplatin
  • Drug: Bevacizumab — also filed as Avastin
  • Drug: Rilvegostomig — also filed as AZD2936
  • Drug: Prednisone/ prednisolone — also filed as Prednisolone
  • Drug: Cisplatin — also filed as Platinol

Primary outcomes

what the primary-completion date above is the date OF
Objective response rate (ORR)
measured From baseline to progressive disease or death (approximately 1 year)
The number of subjects with adverse events/serious adverse events
measured 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)
measured From baseline to PSA response evaluated according to the PCWG3 criteria (approximately 1 year)
Progression free survival (PFS) response (Substudy 4C only)
measured From baseline to progressive disease or death (approximately 1 year)

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