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

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

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230074

Enrollment

360

Registered

2023-05-15

Start date

2023-07-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions

- Substudy 1: Volrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF) - Substudy 2: Rilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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. - Must have a life expectancy of at least 12 weeks. - Adequate organ and bone marrow function. - Has central lab confirmed Claudin 18.2 status at screening from archival tumour collected within past 24 months or from a fresh biopsy when Substudy 3, Substudy 4 is open for recruitment.

Exclusion criteria

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, 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).

Design outcomes

Primary

Measure	Time frame
ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by the Investigator at local site per RECIST 1.1. PFS is defined as 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.	—

Countries

China, Japan, Sourth Korea, Spain, Taiwan, United Kingdom, United States of America

Contacts

Public ContactYusuke Yoshimoto

Astrazeneka K.K

RD-clinical-information-Japan@astrazenec+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026