Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

• Status: Recruiting
• Trial end date: 2025-03-21
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II, open-label, multi-drug, multi-centre study designed to assess the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of novel combination therapies in participants with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

• 18 years or older at the time of signing the ICF.

• Body weight > 35 kg.

• Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

• Has measurable target disease assessed by the Investigator based on RECIST 1.1.

• ECOG PS 0 or 1.

• Life expectancy of at least 12 weeks.

• Adequate organ and bone marrow function.

Exclusion Criteria:

• Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by ISH] or indeterminate gastric or GEJ carcinoma.

• Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression.

• Participants with ascites which cannot be controlled with appropriate interventions.

• Active infectious diseases, including tuberculosis, HIV infection, or hepatitis A/B/C.

• Uncontrolled intercurrent illness.

• Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.

• History of another primary malignancy.

• Previous treatment with an immune-oncology agent.