Study identifier:D967LC00001
ClinicalTrials.gov identifier:NCT04379596
EudraCT identifier:2019-004483-22
CTIS identifier:N/A
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)
gastric cancer
Phase 2
No
Fluorouracil (5-FU), Capecitabine, Oxaliplatin, Trastuzumab deruxtecan, Cisplatin
All
413
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1A T-DXd and 5-fluorouracil (5-FU) | Drug: Fluorouracil (5-FU) 5-FU: administered as an IV infusion Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a |
Experimental: Arm 1B T-DXd and capecitabine | Drug: Capecitabine Capecitabine: administered orally Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a |
Experimental: Arm 1C T-DXd and durvalumab | Biological/Vaccine: Durvalumab Durvalumab: administered as an IV infusion Other Name: MEDI4736 Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a |
Experimental: Arm 1D(b) T-DXd, capecitabine, and oxaliplatin | Drug: Capecitabine Capecitabine: administered orally Drug: Oxaliplatin Oxaliplatin: administered as an IV infusion Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a |
Experimental: Arm 1E(a) T-DXd, 5-FU, and durvalumab | Drug: Fluorouracil (5-FU) 5-FU: administered as an IV infusion Biological/Vaccine: Durvalumab Durvalumab: administered as an IV infusion Other Name: MEDI4736 Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a |
Experimental: Arm 1E(b) T-DXd, capecitabine, and durvalumab | Drug: Capecitabine Capecitabine: administered orally Biological/Vaccine: Durvalumab Durvalumab: administered as an IV infusion Other Name: MEDI4736 Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a |
Active Comparator: Arm 2A Trastuzumab, 5-FU or capecitabine, and cisplatin or oxaliplatin | Drug: Fluorouracil (5-FU) 5-FU: administered as an IV infusion Drug: Capecitabine Capecitabine: administered orally Drug: Oxaliplatin Oxaliplatin: administered as an IV infusion Biological/Vaccine: Trastuzumab Trastuzumab: administered as an IV infusion Drug: Cisplatin Cisplatin: administered as an IV infusion |
Experimental: Arm 2B T-DXd monotherapy | Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a |
Experimental: Arm 2C T-DXd, 5-FU or capecitabine | Drug: Fluorouracil (5-FU) 5-FU: administered as an IV infusion Drug: Capecitabine Capecitabine: administered orally Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a |
Experimental: Arm 2D T-DXd, pembrolizumab and 5-FU or capecitabine | Drug: Fluorouracil (5-FU) 5-FU: administered as an IV infusion Drug: Capecitabine Capecitabine: administered orally Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a Biological/Vaccine: Pembrolizumab Pembrolizumab: administered as an IV infusion |
Experimental: Arm 2E T-DXd and pembrolizumab | Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a Biological/Vaccine: Pembrolizumab Pembrolizumab: administered as an IV infusion |
Experimental: Arm 2F T-DXd, pembrolizumab and 5-FU or capecitabine | Drug: Fluorouracil (5-FU) 5-FU: administered as an IV infusion Drug: Capecitabine Capecitabine: administered orally Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a Biological/Vaccine: Pembrolizumab Pembrolizumab: administered as an IV infusion |
Experimental: Arm 3A T-DXd, Volrustomig and 5-FU or capecitabine | Drug: Fluorouracil (5-FU) 5-FU: administered as an IV infusion Drug: Capecitabine Capecitabine: administered orally Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion Other Name: MEDI5752 |
Experimental: Arm 3B T-DXd, Volrustomig and 5-FU or capecitabine | Drug: Fluorouracil (5-FU) 5-FU: administered as an IV infusion Drug: Capecitabine Capecitabine: administered orally Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion Other Name: MEDI5752 |
Experimental: Arm 4A T-DXd, Rilvegostomig and 5-FU or capecitabine | Drug: Fluorouracil (5-FU) 5-FU: administered as an IV infusion Drug: Capecitabine Capecitabine: administered orally Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a Biological/Vaccine: Rilvegostomig Rilvegostomig: administered as an IV infusion Other Name: AZD2936 |
Experimental: Arm 4B T-DXd, Rilvegostomig and 5-FU or capecitabine | Drug: Fluorouracil (5-FU) 5-FU: administered as an IV infusion Drug: Capecitabine Capecitabine: administered orally Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a Biological/Vaccine: Rilvegostomig Rilvegostomig: administered as an IV infusion Other Name: AZD2936 |