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

Medical condition

gastric cancer

Phase

Phase 2

Healthy volunteers

No

Study drug

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

Sex

All

Estimated Enrollment

413

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 03 Jun 2020
Estimated Primary Completion Date: 30 Jul 2026
Estimated Study Completion Date: 30 Jul 2026

Study design

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

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

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

Inclusion and exclusion criteria