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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
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

Full criteria on ClinicalTrials.gov

Sites (36)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BeijingChinaRecruiting
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HangzhouChinaRecruiting
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HarbinChinaRecruiting
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HefeiChinaRecruiting
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KunmingChinaCompleted
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WuhanChinaRecruiting
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YinchuanChinaRecruiting
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ZhengzhouChinaRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital General Universitario de Elche
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ElcheSpainRecruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
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EdinburghUnited KingdomWithdrawn
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LeedsUnited KingdomRecruiting
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LondonUnited KingdomRecruiting
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OxfordUnited KingdomRecruiting
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ChūōkuJapanRecruiting
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KashiwaJapanRecruiting
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Sunto-gunJapanRecruiting
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SeoulSouth KoreaRecruiting
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HsinchuTaiwanRecruiting
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Kaohsiung CityTaiwanRecruiting
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TaichungTaiwanRecruiting
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TainanTaiwanRecruiting
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TaipeiTaiwanRecruiting
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TaoyuanTaiwanRecruiting
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Baton RougeUnited StatesRecruiting
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Grand RapidsUnited StatesRecruiting
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Los AngelesUnited StatesRecruiting
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New Hyde ParkUnited StatesWithdrawn
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New YorkUnited StatesWithdrawn
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PittsburghUnited StatesWithdrawn
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ShirleyUnited StatesWithdrawn
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The BronxUnited StatesWithdrawn

This page is information, not medical advice. Discuss any trial with your doctor.