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

Recruiting now · Phase 2

Conditions studied: Gastric Cancer

In brief

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.

Key facts

Study ID: NCT05702229
Run by: AstraZeneca
People needed: 163
Starts: 2023-01-16
Expected to finish: 2029-05-31
Last updated by the study team: 2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 i s open for recruitment.

You may not qualify if…

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 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 is open for recruitment).

Where it is running

Research Site — Oxford, United Kingdom (enrolling)
Research Site — Kaohsiung City, Taiwan (enrolling)
Research Site — Taichung, Taiwan (enrolling)
Research Site — Tainan, Taiwan (enrolling)
Research Site — Taipei, Taiwan (enrolling)
Research Site — Taipei, Taiwan (enrolling)
Research Site — Taoyuan, Taiwan (enrolling)
Research Site — Leeds, United Kingdom (enrolling)
Research Site — London, United Kingdom (enrolling)
Research Site — Los Angeles, California, United States (enrolling)
Research Site — Baton Rouge, Louisiana, United States (enrolling)
Research Site — Grand Rapids, Michigan, United States (enrolling)
Research Site — New York, New York, United States (enrolling)
Research Site — Beijing, China (enrolling)
Research Site — Hangzhou, China (enrolling)
Research Site — Hangzhou, China (enrolling)
Research Site — Harbin, China (enrolling)
Research Site — Hefei, China (enrolling)
Research Site — Wuhan, China (enrolling)
Research Site — Yinchuan, China (enrolling)
Research Site — Zhengzhou, China (enrolling)
Research Site — Chūōku, Japan (enrolling)
Research Site — Kashiwa, Japan (enrolling)
Research Site — Sunto-gun, Japan (enrolling)
Research Site — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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