A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
NCT07069712 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-05-18
Summary
GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.
Conditions
- Gastroesophageal Adenocarcinoma
Interventions
- DRUG
-
AZD0901
AZD0901 will be administered as an IV infusion.
- DRUG
-
Rilvegostomig will be administered as an IV infusion.
- DRUG
-
Trastuzumab Deruxtecan (T-DXd)
T-DXd will be administered as an IV infusion.
- DRUG
-
Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care.
- DRUG
-
5-Fluorouracil (5-FU)
5-FU (Fluoropyrimidine) will be administered as an IV infusion as chemotherapy standard of care.
- DRUG
-
FLOT Chemotherapy
FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion.
Sponsors & Collaborators
-
Parexel
collaborator INDUSTRY - lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-17
- Primary Completion
- 2027-01-28
- Completion
- 2028-09-06
- FDA Drug
- Yes
Countries
- United States
- Canada
- China
- Georgia
- Italy
- Japan
- Poland
- Spain
- Taiwan
- Turkey (Türkiye)
- United Kingdom
Study Locations
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