A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma
Sponsor: AstraZeneca
ClinicalTrials ID:NCT07069712
The GEMINI-PeriOp GC Phase II study evaluates safety, tolerability, PK, and anti-tumor activity of novel agents or combinations in resectable gastric, GEJ, or esophageal adenocarcinoma. Eligible participants have specific biomarker profiles and ECOG 0-1. Interventions include AZD0901, Rilvegostomig, T-DXd, Capecitabine, 5-FU, and FLOT chemotherapy.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
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
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 19713 | Newark | Delaware |
| Research Site | 20007 | Washington D.C. | District of Columbia |
| Research Site | 66205 | Fairway | Kansas |
| Research Site | 49444 | North Shores | Michigan |
| Research Site | 10032 | New York | New York |
| Research Site | 10065 | New York | New York |
| Research Site | 15232 | Pittsburgh | Pennsylvania |
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