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

Description

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.

Conditions

Gastric Cancer

Study Overview

Study Details

Study 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.

An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

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

Condition
Gastric Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Research Site, Los Angeles, California, United States, 90017

Los Angeles

Research Site, Los Angeles, California, United States, 90095

Baton Rouge

Research Site, Baton Rouge, Louisiana, United States, 70817

Grand Rapids

Research Site, Grand Rapids, Michigan, United States, 49503

Bronx

Research Site, Bronx, New York, United States, 10469

New Hyde Park

Research Site, New Hyde Park, New York, United States, 11042

New York

Research Site, New York, New York, United States, 10028

New York

Research Site, New York, New York, United States, 11210

Shirley

Research Site, Shirley, New York, United States, 11967

Pittsburgh

Research Site, Pittsburgh, Pennsylvania, United States, 15212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2026-03-31