Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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).
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Gastric Cancer
Age
18+
Phase
PHASE2
Participants Needed
240
Est. Completion Date
Mar 31, 2026
Treatment Type
INTERVENTIONAL
Sponsor
AstraZeneca
ClinicalTrials.gov NCT Identifier
NCT05702229
Study Number
D7986C00001
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