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NCT07069712PHASE2Recruiting

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

AstraZeneca

Start Date

7/17/2025

Completion Date

9/6/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 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

Interventions

DRUG

AZD0901

DRUG

Rilvegostomig

DRUG

Trastuzumab Deruxtecan (T-DXd)

DRUG

Capecitabine

DRUG

5-Fluorouracil (5-FU)

DRUG

FLOT Chemotherapy

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Conditions

Gastroesophageal Adenocarcinoma

Locations

Research Site

Newark, Delaware 19713

United States

Research Site

Washington D.C., District of Columbia 20007

United States

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Fairway, Kansas 66205

United States

Research Site

North Shores, Michigan 49444

United States

Research Site

New York, New York 10032

United States

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New York, New York 10065

United States

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Pittsburgh, Pennsylvania 15232

United States

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Toronto, Ontario M5G 2M9

Canada

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Montreal, Quebec H2X 3E4

Canada

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Montreal, Quebec H4A 3J1

Canada

Research Site

Beijing, 100142

China

Research Site

Changchun, 130021

China

Research Site

Changzhi, 046000

China

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Chengdu, 610041

China

Research Site

Chengdu, 610042

China

Research Site

Fuzhou, 350014

China

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Hangzhou, 310003

China

Research Site

Hangzhou, 310014

China

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Kunming, 650118

China

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Qingdao, 266003

China

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Shanghai, 200025

China

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Shijiazhuang, 050020

China

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Tbilisi, 0112

Georgia

Research Site

Tbilisi, 0114

Georgia

Research Site

Tbilisi, 0144

Georgia

Research Site

Tbilisi, 0159

Georgia

Research Site

Florence, 50134

Italy

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Milan, 20133

Italy

Research Site

Milan, 20141

Italy

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Milan, 20162

Italy

Research Site

Modena, 41124

Italy

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Pisa, 56100

Italy

Research Site

Rozzano, 20089

Italy

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Udine, 33100

Italy

Research Site

Vicenza, 36100

Italy

Research Site

Chūōku, 104-0045

Japan

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Fukuoka, 812-8582

Japan

Research Site

Hidaka-shi, 350-1298

Japan

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Kashiwa, 277-8577

Japan

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Kitaadachi-gun, 362-0806

Japan

Research Site

Kōtoku, 135-8550

Japan

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Nagoya, 464-8681

Japan

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Osaka, 541-8567

Japan

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Osaka, 558-8558

Japan

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Suita-shi, 565-0871

Japan

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Yokohama, 241-8515

Japan

Research Site

Bialystok, 15-027

Poland

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Warsaw, 02-034

Poland

Research Site

Barcelona, 08035

Spain

Research Site

Barcelona, 08036

Spain

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Elche, 03203

Spain

Research Site

Madrid, 28007

Spain

Research Site

Málaga, 29010

Spain

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Ourense, 32005

Spain

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Oviedo, 33011

Spain

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Santander, 39008

Spain

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Valencia, 46010

Spain

Research Site

Kaohsiung City, 80756

Taiwan

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Tainan, 704

Taiwan

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Taipei, 11217

Taiwan

Research Site

Taoyuan, 33305

Taiwan

Research Site

Adapazarı, 54100

Turkey (Türkiye)

Research Site

Erzurum, 25240

Turkey (Türkiye)

Research Site

Fatih-Istanbul, 34098

Turkey (Türkiye)

Research Site

Istanbul, 34722

Turkey (Türkiye)

Research Site

Bristol, BS2 8ED

United Kingdom

Research Site

Dundee, DD1 9SY

United Kingdom

Research Site

Headington, OX3 7LJ

United Kingdom

Research Site

London, E1 1BB

United Kingdom

Research Site

Norwich, NR4 7UY

United Kingdom