RecruitingPhase 2NCT07069712

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)


Sponsor

AstraZeneca

Enrollment

100 participants

Start Date

Jul 17, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing new drug combinations as treatment given before and after surgery (called perioperative therapy) for people with resectable (surgically removable) advanced stomach, gastroesophageal junction, or esophageal cancer — using targeted therapies based on specific tumor protein markers. **You may be eligible if...** - You have confirmed adenocarcinoma of the stomach, gastroesophageal junction, or esophagus that can be surgically removed - Your tumor tests positive for CLDN18.2 and is HER2-negative (sub-study 1), or HER2-positive (sub-study 2), or other criteria per sub-study 3 - You have not yet received any treatment for this cancer - You are in good physical condition and your organ function meets study requirements **You may NOT be eligible if...** - You have already had surgery or anti-cancer treatment for this cancer - You have active autoimmune disease or are on immunosuppressive treatment - Your cancer has spread to distant organs - You have active hepatitis B or a history of interstitial lung disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD0901

AZD0901 will be administered as an IV infusion.

DRUGRilvegostomig

Rilvegostomig will be administered as an IV infusion.

DRUGTrastuzumab Deruxtecan (T-DXd)

T-DXd will be administered as an IV infusion.

DRUGCapecitabine

Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care.

DRUG5-Fluorouracil (5-FU)

5-FU (Fluoropyrimidine) will be administered as an IV infusion as chemotherapy standard of care.

DRUGFLOT Chemotherapy

FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion.


Locations(70)

Research Site

Newark, Delaware, United States

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Washington D.C., District of Columbia, United States

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Fairway, Kansas, United States

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North Shores, Michigan, United States

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New York, New York, United States

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New York, New York, United States

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Pittsburgh, Pennsylvania, United States

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Beijing, China

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Changchun, China

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Changzhi, China

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Chengdu, China

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Chengdu, China

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Fuzhou, China

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Hangzhou, China

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Hangzhou, China

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Kunming, China

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Qingdao, China

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Shanghai, China

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Shijiazhuang, China

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Tbilisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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Tbilisi, Georgia

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Florence, Italy

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Milan, Italy

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Milan, Italy

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Milan, Italy

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Modena, Italy

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Pisa, Italy

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Rozzano, Italy

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Udine, Italy

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Vicenza, Italy

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Chūōku, Japan

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Fukuoka, Japan

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Hidaka-shi, Japan

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Kashiwa, Japan

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Kitaadachi-gun, Japan

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Kōtoku, Japan

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Nagoya, Japan

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Osaka, Japan

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Osaka, Japan

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Suita-shi, Japan

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Yokohama, Japan

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Bialystok, Poland

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Warsaw, Poland

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Barcelona, Spain

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Barcelona, Spain

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Elche, Spain

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Madrid, Spain

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Málaga, Spain

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Ourense, Spain

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Oviedo, Spain

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Santander, Spain

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Valencia, Spain

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Kaohsiung City, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Adapazarı, Turkey (Türkiye)

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Erzurum, Turkey (Türkiye)

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Fatih-Istanbul, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Bristol, United Kingdom

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Dundee, United Kingdom

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Headington, United Kingdom

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London, United Kingdom

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Norwich, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07069712


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