A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)
AstraZeneca
100 participants
Jul 17, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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
- Body weight \> 35 kg
Exclusion Criteria9
- 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
- Participants with history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis
- History of another primary malignancy
- Participants with any known or suspicious distant metastasis
- Uncontrolled hepatitis B and/or chronic or active hepatitis B
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention
Interventions
AZD0901 will be administered as an IV infusion.
Rilvegostomig will be administered as an IV infusion.
T-DXd will be administered as an IV infusion.
Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care.
5-FU (Fluoropyrimidine) will be administered as an IV infusion as chemotherapy standard of care.
FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion.
Locations(70)
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NCT07069712