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
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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(a) T-DXd, 5-FU, and oxaliplatin | Drug: Fluorouracil (5-FU) 5-FU: administered as an IV infusion Drug: Oxaliplatin Oxaliplatin: administered as an IV infusion 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, and 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 Drug: Trastuzumab deruxtecan T-DXd: administered as an IV infusion Other Name: DS-8201a |
| Experimental: Arm 2D T-DXd, 5-FU or capecitabine, and pembrolizumab | 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 |
