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)
AstraZeneca
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.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 disord…
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 SiteNewark, Delaware
- Research SiteWashington D.C., District of Columbia
- Research SiteFairway, Kansas
- Research SiteNorth Shores, Michigan
- Research SiteNew York, New York
- Research SiteNew York, New York