A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

Where this trial is running

• Research Site, Newark, Delaware, United States
• Research Site, Washington D.C., District of Columbia, United States
• Research Site, Fairway, Kansas, United States
• Research Site, North Shores, Michigan, United States
• Research Site, New York, New York, United States
• Research Site, New York, New York, United States
• Research Site, Pittsburgh, Pennsylvania, United States
• Research Site, Toronto, Ontario, Canada
• Research Site, Montreal, Quebec, Canada
• Research Site, Montreal, Quebec, Canada
• Research Site, Beijing, China
• Research Site, Changchun, China

+ 58 more sites.

Who to contact

AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07069712.