NCT05702229RecruitingPhase 2
Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction 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
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 163 (estimated)
- First submitted
- 7 Dec 2022
- Start date
- 16 Jan 2023
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- AstraZeneca
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05702229
- EU CT number
- 2024-510977-27-00
- EudraCT number
- 2022-002840-29
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 163
- From 16 Jan 2023 to the primary completion date, 30 Nov 2027
- 36 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.
- 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).
Other illness
- Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression.
- Active infectious diseases, including tuberculosis, HIV infection, or hepatitis B/C.
- Uncontrolled intercurrent illness.
- History of another primary malignancy.
Other
- Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by in situhybridisation) or indeterminate gastric or GEJ carcinoma.
- Participants with ascites which cannot be controlled with appropriate interventions.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.