Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2+ Gastric Cancer (DESTINY-Gastric03) - DG-03

Study identifier:D967LC00001

ClinicalTrials.gov identifier:NCT04379596

EudraCT identifier:2019-004483-22

CTIS identifier:N/A

Recruiting

Official Title

A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants with HER2 Overexpressing Gastric Cancer (DESTINY-Gastric03)

Medical condition

gastric cancer

Phase

Phase 2

Healthy volunteers

No

Study drug

Fluorouracil (5-FU), Fluorouracil (5-FU), Fluorouracil (5-FU), Fluorouracil (5-FU), Fluorouracil (5-FU), Fluorouracil (5-FU), Capecitabine, Capecitabine, Capecitabine, Capecitabine, Capecitabine, Capecitabine, Oxaliplatin, Oxaliplatin, Oxaliplatin, Oxaliplatin, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Trastuzumab deruxtecan, Cisplatin

Sex

All

Actual enrollment

357

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 03 Jun 2020
Estimated Primary Completion Date: 29 Sept 2025
Estimated Study Completion Date: 29 Sept 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 May 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo

Inclusion and exclusion criteria