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
3 other identifiers
interventional
163
7 countries
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Jan 2023
Longer than P75 for phase_2 gastric-cancer
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2022
CompletedStudy Start
First participant enrolled
January 16, 2023
CompletedFirst Posted
Study publicly available on registry
January 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2029
March 18, 2026
March 1, 2026
4.9 years
December 7, 2022
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
ORR (per RECIST 1.1 as assessed by Investigator)
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.
Through substudy completion, an average of 2 years
PFS6 (per RECIST 1.1 as assessed by Investigator)
the proportion of participants alive and progression-free at 6 months.
Through substudy completion, an average of 2 years
Secondary Outcomes (4)
PFS per RECIST 1.1 as assessed by the Investigator
Through substudy completion, an average of 2 years
OS
Through substudy completion, an average of 2 years
other safety related endpoints
Through substudy completion, an average of 2 years
DoR per RECIST 1.1 based on Investigator assessment.
Through substudy completion, an average of 2 years
Study Arms (6)
Substudy 1
EXPERIMENTALVolrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Substudy 2
EXPERIMENTALRilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Substudy 3
EXPERIMENTALAZD0901 plus volrustomig and 5-fluorouracil or capecitabine
Substudy 4, Cohort 4a1
EXPERIMENTALSonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil or capecitabine
Substudy 4, Cohort 4a2
EXPERIMENTALSonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil
Substudy 4, Cohort 4b
EXPERIMENTALSonesitatug vedotin (AZD0901) plus capecitabine
Interventions
an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion
5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available)
an anti Claudin18.2 ADC; IV infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (44)
Research Site
Los Angeles, California, 90017, United States
Research Site
Los Angeles, California, 90095, United States
Research Site
Baton Rouge, Louisiana, 70817, United States
Research Site
Grand Rapids, Michigan, 49503, United States
Research Site
New Hyde Park, New York, 11042, United States
Research Site
New York, New York, 10028, United States
Research Site
New York, New York, 10065, United States
Research Site
New York, New York, 11210, United States
Research Site
Shirley, New York, 11967, United States
Research Site
The Bronx, New York, 10469, United States
Research Site
Pittsburgh, Pennsylvania, 15212, United States
Research Site
Beijing, 100142, China
Research Site
Hangzhou, 310003, China
Research Site
Hangzhou, 310020, China
Research Site
Harbin, 150081, China
Research Site
Hefei, 230031, China
Research Site
Kunming, 650118, China
Research Site
Wuhan, 430079, China
Research Site
Yinchuan, 750004, China
Research Site
Zhengzhou, 450052, China
Research Site
Chūōku, 104-0045, Japan
Research Site
Kashiwa, 227-8577, Japan
Research Site
Sunto-gun, 411-8777, Japan
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Barcelona, 08035, Spain
Research Site
Elche(Alicante), 03202, Spain
Research Site
L'Hospitalet de Llobregat, 08908, Spain
Research Site
Madrid, 28007, Spain
Research Site
Madrid, 28040, Spain
Research Site
Santander, 39008, Spain
Research Site
Hsinchu, 300, Taiwan
Research Site
Kaohsiung City, 80756, Taiwan
Research Site
Taichung, 404, Taiwan
Research Site
Tainan, 70403, Taiwan
Research Site
Taipei, 10002, Taiwan
Research Site
Taipei, 11259, Taiwan
Research Site
Taoyuan District, 333, Taiwan
Research Site
Edinburgh, EH4 2XU, United Kingdom
Research Site
Leeds, LS9 7TF, United Kingdom
Research Site
London, EC1M 6BQ, United Kingdom
Research Site
Oxford, OX3 7LE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2022
First Posted
January 27, 2023
Study Start
January 16, 2023
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
May 31, 2029
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.