About this trial
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.
Eligibility criteria
Qualifiers
Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease
Participants who are CLDN18.2-positive and HER2-negative in Sub-study 1 or HER2-positive in Sub-study 2; no specific requirements for Sub-study 3
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ and bone marrow function
Disqualifiers
Participants had any prior anti-cancer treatment or surgery for the current gastric, GEJ, or esophageal cancer.
Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment
Central nervous system (CNS) pathology
Uncontrolled infections
Trial design
Treatments tested in this trial
- AZD0901
- Rilvegostomig
- Trastuzumab Deruxtecan (T-DXd)
- Capecitabine
- 5-Fluorouracil (5-FU)
- FLOT Chemotherapy
Treatment groups
Sponsors and collaborators
AstraZeneca
Lead sponsor
Parexel
Collaborator