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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)

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease
* Participants who are CLDN18.2-positive 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 Criteria:

* 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

About the study

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.

What is being tested

• Sonesitatug Vedotin (drug)
• Rilvegostomig (drug)
• Trastuzumab Deruxtecan (T-DXd) (drug)
• Capecitabine (drug)
• 5-Fluorouracil (5-FU) (drug)
• FLOT Chemotherapy (drug)

Sponsor: AstraZeneca · Participants: 100 · Started: Jul 17, 2025

Contact the study team

• AstraZeneca Clinical Study Information Center · Phone: 1-877-240-9479

Official record on ClinicalTrials.gov — NCT07069712

Locations in the U.S.

Conditions

• Stomach Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.