An official website of the United States government
A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
Trial Status: active
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.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07069712.
Locations matching your search criteria
United States
Kansas
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
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