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
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 Oct 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(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, 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 |
| Experimental: Arm 2F T-DXd, chemotherapy (FP) 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 3A T-DXd, FP and BSP (MEDI5752) | 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: MEDI5752 MEDI5752: administered as an IV infusion |
| Experimental: Arm 3B T-DXd, FP and BSP (MEDI5752) | 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: MEDI5752 MEDI5752: administered as an IV infusion |
