Summary

Eligibility
for people ages 18-130 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Zev A. Wainberg, MD (ucla)
Headshot of Zev A. Wainberg
Zev A. Wainberg

Description

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.

Official Title

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

Details

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).

Keywords

Endometrial Cancer, Gastric Cancer, Metastatic Castration-resistant Prostate Cancer, Ovarian Cancer, Colorectal Cancer, Urothelial Cancer, Biliary Tract Cancer, TROPION-PanTumor03, Datopotamab Deruxtecan (Dato-DXd), Solid Tumours, Antibody-drug conjugate (ADC), Trophoblast cell surface protein 2 (TROP2), Endometrial Neoplasms, Biliary Tract Neoplasms, Leucovorin, Prednisone, Prednisolone, Methylprednisolone Acetate, Methylprednisolone, Methylprednisolone Hemisuccinate, Prednisolone acetate, Bevacizumab, Carboplatin, Capecitabine, Fluorouracil, Prednisolone hemisuccinate, Prednisolone phosphate, 5-Fluorouracil, Volrustomig, Leucovorin LV, Rilvegostomig, Prednisone/ prednisolone, Cisplatin, Substudy-1A, Substudy-2A, Substudy-2B, Substudy-3A, Substudy-3C, Substudy-4A, Substudy-4C, Substudy-5A, Substudy-5B, Substudy-6A, Substudy-6B, Substudy-6C, Substudy-6D, Substudy-7A

Eligibility

Locations

  • Research Site accepting new patients
    Los Angeles California 90095 United States
  • Research Site withdrawn
    San Diego California 92103 United States
  • Research Site accepting new patients
    Santa Rosa California 95403 United States

Lead Scientist at University of California Health

  • Zev A. Wainberg, MD (ucla)
    Zev Wainberg, M.D., holds the Estelle, Abe, and Marjorie Sanders Chair in Cancer Research.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT05489211
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 582 study participants
Last Updated