Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
NCT04379596 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 450
Last updated 2026-05-13
Summary
DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients.
Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or immunotherapy administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing. T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered to HER2-expressing gastric, GEJ and esophageal cancer patients who have not received prior treatment for advanced/metastatic disease will show preliminary evidence of anti-tumour activity and the potential to become a therapeutic option for this patient population.
Conditions
Interventions
- BIOLOGICAL
-
Durvalumab: administered as an IV infusion
- DRUG
-
Oxaliplatin: administered as an IV infusion
- BIOLOGICAL
-
Trastuzumab: administered as an IV infusion
- DRUG
-
T-DXd: administered as an IV infusion
- DRUG
-
Cisplatin: administered as an IV infusion
- BIOLOGICAL
-
Pembrolizumab: administered as an IV infusion
- BIOLOGICAL
-
Volrustomig
Volrustomig: administered as an IV infusion
- BIOLOGICAL
-
Rilvegostomig: administered as an IV infusion
- DRUG
-
Fluorouracil (5-FU)
5-FU: administered as an IV infusion
- DRUG
-
Capecitabine: administered orally
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 130 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-03
- Primary Completion
- 2027-06-01
- Completion
- 2027-06-01
- FDA Drug
- Yes
Countries
- United States
- Brazil
- Canada
- China
- Germany
- Italy
- Japan
- Netherlands
- Poland
- Russia
- South Korea
- Spain
- Taiwan
- United Kingdom
Study Locations
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