NCT07069712

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Phase II, open-label, multi-drug, multi-center platform study consists of individual sub-studies, each allows the assessment of multiple novel agents or novel combinations. Participants will be assigned across 3 sub-studies, to have sufficient evaluable participants of the confirmed recommended dose by Safety Review Committee (SRC) for study intervention in each corresponding sub-study.

Conditions

• Gastroesophageal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	AZD0901	AZD0901 will be administered as an IV infusion.
DRUG	Rilvegostomig	Rilvegostomig will be administered as an IV infusion.
DRUG	Trastuzumab Deruxtecan (T-DXd)	T-DXd will be administered as an IV infusion.
DRUG	Capecitabine	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.

Timeline

• Start date: 2025-07-17
• Primary completion: 2027-01-28
• Completion: 2028-09-06
• First posted: 2025-07-17
• Last updated: 2026-03-10

Locations

70 sites across 11 countries: United States, Canada, China, Georgia, Italy, Japan, Poland, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study