RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT07069712

Registry updated: 2026-10-16

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Description

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.

Interventions

Sonesitatug Vedotin (Drug)
Sonesitatug Vedotin will be administered as an IV infusion.
Rilvegostomig (Drug)
Rilvegostomig will be administered as an IV infusion.
Trastuzumab Deruxtecan (T-DXd) (Drug)
T-DXd will be administered as an IV infusion.
Capecitabine (Drug)
Capecitabine (Fluoropyrimidine) will be administered orally as chemotherapy standard of care.
5-Fluorouracil (5-FU) (Drug)
5-FU (Fluoropyrimidine) will be administered as a continuous IV infusion as chemotherapy standard of care.
FLOT Chemotherapy (Drug)
FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion.
Calcium folinate (Drug)
Calcium folinate will be administered as an IV infusion as chemotherapy standard of care.

Eligibility criteria

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

Conditions

Gastroesophageal Adenocarcinoma

Locations

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
Research Site — Changzhi, China
Research Site — Chengdu, China
Research Site — Chengdu, China
Research Site — Fuzhou, China
Research Site — Hangzhou, China
Research Site — Hangzhou, China
Research Site — Kunming, China
Research Site — Qingdao, China
Research Site — Shanghai, China
Research Site — Shijiazhuang, China
Research Site — Tbilisi, Georgia
Research Site — Tbilisi, Georgia
Research Site — Tbilisi, Georgia
Research Site — Tbilisi, Georgia
Research Site — Florence, Italy
Research Site — Milan, Italy
Research Site — Milan, Italy
Research Site — Milan, Italy
Research Site — Modena, Italy
Research Site — Pisa, Italy
Research Site — Rozzano, Italy
Research Site — Udine, Italy
Research Site — Vicenza, Italy
Research Site — Chūōku, Japan
Research Site — Fukuoka, Japan
Research Site — Hidaka-shi, Japan
Research Site — Kashiwa, Japan
Research Site — Kitaadachi-gun, Japan
Research Site — Kōtoku, Japan
Research Site — Nagoya, Japan
Research Site — Osaka, Japan
Research Site — Osaka, Japan
Research Site — Suita-shi, Japan
Research Site — Yokohama, Japan
Research Site — Bialystok, Poland
Research Site — Warsaw, Poland
Research Site — Barcelona, Spain
Research Site — Barcelona, Spain
Research Site — Elche, Spain
Research Site — Madrid, Spain
Research Site — Málaga, Spain
Research Site — Ourense, Spain
Research Site — Oviedo, Spain
Research Site — Santander, Spain
Research Site — Valencia, Spain
Research Site — Kaohsiung City, Taiwan
Research Site — Tainan, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taoyuan, Taiwan
Research Site — Adapazarı, Turkey (Türkiye)
Research Site — Erzurum, Turkey (Türkiye)
Research Site — Fatih-Istanbul, Turkey (Türkiye)
Research Site — Istanbul, Turkey (Türkiye)
Research Site — Bristol, United Kingdom
Research Site — Dundee, United Kingdom
Research Site — Headington, United Kingdom
Research Site — London, United Kingdom
Research Site — Norwich, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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