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Recruiting
NCT05702229
Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Conditions: Gastric Cancer
Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 80
Sponsor: AstraZeneca
Location: China
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.
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 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.
Source: ClinicalTrials.gov (NCT05702229). StuddyBuddy aggregates publicly available trial information.