RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-01-16
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05702229

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older at the time of signing the ICF.
  2. * Body weight \> 35 kg.
  3. * Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
  4. * Has measurable target disease assessed by the Investigator based on RECIST 1.1.
  5. * ECOG PS zero or one.
  6. * Life expectancy of at least 12 weeks.
  7. * Adequate organ and bone marrow function.
  8. * 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.
  1. * Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by in situhybridisation) or indeterminate gastric or GEJ carcinoma.
  2. * Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression.
  3. * Participants with ascites which cannot be controlled with appropriate interventions.
  4. * Active infectious diseases, including tuberculosis, HIV infection, or hepatitis A/B/C.
  5. * Uncontrolled intercurrent illness.
  6. * Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.
  7. * History of another primary malignancy.
  8. * Previous treatment with an immune-oncology agent.
  9. * 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).

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Los Angeles, California, 90017
United States
Research Site
Los Angeles, California, 90095
United States
Research Site
Baton Rouge, Louisiana, 70817
United States
Research Site
Grand Rapids, Michigan, 49503
United States
Research Site
Bronx, New York, 10469
United States
Research Site
New Hyde Park, New York, 11042
United States
Research Site
New York, New York, 10028
United States
Research Site
New York, New York, 11210
United States
Research Site
Shirley, New York, 11967
United States
Research Site
Pittsburgh, Pennsylvania, 15212
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-16
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-01-16
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • Locally advanced
  • Metatstatic
  • Gastric adenocarcinoma
  • GEJ adenocarcinoma
  • GEMINI-Gastric

Additional Relevant MeSH Terms

  • Gastric Cancer