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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • AZD0901
  • Rilvegostomig
  • Trastuzumab Deruxtecan (T-DXd)
  • Capecitabine
  • 5-Fluorouracil (5-FU)
  • FLOT Chemotherapy

Treatment groups

100 Participants
are divided into 3 treatment groups

Sponsors and collaborators

AstraZeneca

Lead sponsor

Parexel

Collaborator