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

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05702229

Patient View

This Phase II, open-label study involves 240 participants across 6 substudies, evaluating novel drug combinations for advanced gastric or GEJ adenocarcinoma. Eligible participants are adults with untreated, measurable disease and adequate organ function. Exclusions include HER2-positive status and prior immune-oncology treatments. Interventions include bispecific antibodies and chemotherapy regimens.

Patient Parameters

Program Overview

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.

Description

Approximately 240 participants will be assigned across 6 substudies, with approximately 40 evaluable participants of the confirmed recommend dose by SRC for study intervention in each corresponding substudy.

Eligibility 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 zero or one.
  • Life expectancy of at least 12 weeks.
  • Adequate organ and bone marrow function.
  • Has central lab confirmed Claudin18.2 status at screening from archival tumour collected within past 24 months or from a fresh biopsy when Substudy 3, Substudy 4 or Substudy 6 is open for recruitment.

Exclusion Criteria

  • Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by in situhybridisation) 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.
  • Previous treatment with any modalities of Claudin18.2 target therapy or MMAE exposure (when Substudy 3, Substudy 4, or Substudy 6 is open for recruitment).

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