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NCT Number: NCT05702229

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Beijing, China

Loading trial locations.

About this study

Approximately 360 participants will be assigned across 4 substudies, with approximately 60 evaluable participants of the confirmed recommend dose by SRC for study intervention in each corresponding substudy/cohort.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 i s open for recruitment.

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 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).

Treatment and study plan

Rilvegostomig

Drug

an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion

Volrustomig

Drug

an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion

FOLFOX

Drug

5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available)

XELOX

Drug

capecitabine and oxaliplatin

AZD0901

Drug

an anti Claudin18.2 ADC; IV infusion

5-fluorouracil

Drug

5-FU, IV infusion

Capecitabine

Drug

Oral take

Primary outcomes

  1. ORR (per RECIST 1.1 as assessed by Investigator)

    Time frame: Through substudy completion, an average of 2 years

    the proportion of participants who have a confirmed complete response or confirmed partial response, as determined by the Investigator at local site per RECIST 1.1.

  2. PFS6 (per RECIST 1.1 as assessed by Investigator)

    Time frame: Through substudy completion, an average of 2 years

    the proportion of participants alive and progression-free at 6 months.

Secondary outcomes

  1. PFS per RECIST 1.1 as assessed by the Investigator

    Time frame: Through substudy completion, an average of 2 years

    the time from the start of study intervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression.

  2. OS

    Time frame: Through substudy completion, an average of 2 years

    the time from the start of study intervention until the date of death due to any cause.

  3. other safety related endpoints

    Time frame: Through substudy completion, an average of 2 years

    Incidence of AEs, AESIs, and SAEs.

  4. DoR per RECIST 1.1 based on Investigator assessment.

    Time frame: Through substudy completion, an average of 2 years

    the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 by the Investigator at local site or death due to any cause in the absence of disease progression.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Jan 27, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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