Recruiting NCT05702229

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

Phase II Interventional Gastric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Rilvegostomig, Volrustomig, FOLFOX, XELOX.
Who it may be relevant to: Registry conditions: Gastric Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, China, Japan, South Korea, Spain +2
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Detailed description

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.

Interventions

Drug Rilvegostomig
an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion
Drug Volrustomig
an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion
Drug FOLFOX
5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available)
Drug XELOX
capecitabine and oxaliplatin
Drug AZD0901
an anti Claudin18.2 ADC; IV infusion
Drug 5-Fluorouracil
5-FU, IV infusion
Drug Capecitabine
Oral take

Primary outcome measures

ORR (per RECIST 1.1 as assessed by Investigator) [Time frame: Through substudy completion, an average of 2 years]
PFS6 (per RECIST 1.1 as assessed by Investigator) [Time frame: Through substudy completion, an average of 2 years]

Secondary outcome measures (4)

PFS per RECIST 1.1 as assessed by the Investigator [Time frame: Through substudy completion, an average of 2 years]
OS [Time frame: Through substudy completion, an average of 2 years]
other safety related endpoints [Time frame: Through substudy completion, an average of 2 years]
DoR per RECIST 1.1 based on Investigator assessment. [Time frame: Through substudy completion, an average of 2 years]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 11 centers

Research Site — Los Angeles
Research Site — Los Angeles
Research Site — Baton Rouge
Research Site — Grand Rapids
Research Site — New Hyde Park
Research Site — New York
Research Site — New York
Research Site — New York
… and 3 more centers

China · 9 centers

Research Site — Beijing
Research Site — Hangzhou
Research Site — Hangzhou
Research Site — Harbin
Research Site — Hefei
Research Site — Kunming
Research Site — Wuhan
Research Site — Yinchuan
… and 1 more center

Taiwan · 7 centers

Research Site — Hsinchu
Research Site — Kaohsiung City
Research Site — Taichung
Research Site — Tainan
Research Site — Taipei
Research Site — Taipei
Research Site — Taoyuan

Spain · 6 centers

Research Site — Barcelona
Research Site — Elche(Alicante)
Research Site — L'Hospitalet de Llobregat
Research Site — Madrid
Research Site — Madrid
Research Site — Santander

South Korea · 4 centers

Research Site — Seoul
Research Site — Seoul
Research Site — Seoul
Research Site — Seoul

United Kingdom · 4 centers

Research Site — Edinburgh
Research Site — Leeds
Research Site — London
Research Site — Oxford

Japan · 3 centers

Research Site — Chūōku
Research Site — Kashiwa
Research Site — Sunto-gun

Identifiers

NCT: NCT05702229 · D7986C00001 · 2024-510977-27-00 · 2022-002840-29

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗