Gastric CancerPhase 2NCT05702229
Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Rilvegostomig, Volrustomig and FOLFOX in people with Gastric Cancer, run by AstraZeneca at 44 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Rilvegostomig, Volrustomig and FOLFOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 44 sitesin 7 countries
- Study dates
- 16 Jan 2023to 31 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
44 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
44 sites in 7 countries
United States11 sites, 4 recruiting
- Recruiting
Research Site
Baton Rouge, Louisiana, 70817
- Recruiting
Research Site
Grand Rapids, Michigan, 49503
- Recruiting
Research Site
Los Angeles, California, 90017
- Withdrawn
Research Site
Los Angeles, California, 90095
- Withdrawn
Research Site
New Hyde Park, New York, 11042
- Withdrawn
Research Site
New York, New York, 10028
- Recruiting
Research Site
New York, New York, 10065
- Withdrawn
Research Site
New York, New York, 11210
- Withdrawn
Research Site
Pittsburgh, Pennsylvania, 15212
- Withdrawn
Research Site
Shirley, New York, 11967
- Withdrawn
Research Site
The Bronx, New York, 10469
China9 sites, 8 recruiting
- Recruiting
Research Site
Beijing, 100142
- Recruiting
Research Site
Hangzhou, 310003
- Recruiting
Research Site
Hangzhou, 310020
- Recruiting
Research Site
Harbin, 150081
- Recruiting
Research Site
Hefei, 230031
- Completed
Research Site
Kunming, 650118
- Recruiting
Research Site
Wuhan, 430079
- Recruiting
Research Site
Yinchuan, 750004
- Recruiting
Research Site
Zhengzhou, 450052
Taiwan7 sites, 7 recruiting
- Recruiting
Research Site
Hsinchu, 300
- Recruiting
Research Site
Kaohsiung City, 80756
- Recruiting
Research Site
Taichung, 404
- Recruiting
Research Site
Tainan, 70403
- Recruiting
Research Site
Taipei, 10002
- Recruiting
Research Site
Taipei, 11259
- Recruiting
Research Site
Taoyuan, 333
Spain6 sites, 6 recruiting
- Recruiting
Research Site
Barcelona, 08035
- Recruiting
Research Site
Elche(Alicante), 03202
- Recruiting
Research Site
L'Hospitalet de Llobregat, 08908
- Recruiting
Research Site
Madrid, 28007
- Recruiting
Research Site
Madrid, 28040
- Recruiting
Research Site
Santander, 39008
South Korea4 sites, 4 recruiting
- Recruiting
Research Site
Seoul, 03080
- Recruiting
Research Site
Seoul, 03722
- Recruiting
Research Site
Seoul, 05505
- Recruiting
Research Site
Seoul, 06351
United Kingdom4 sites, 3 recruiting
- Withdrawn
Research Site
Edinburgh, EH4 2XU
- Recruiting
Research Site
Leeds, LS9 7TF
- Recruiting
Research Site
London, EC1M 6BQ
- Recruiting
Research Site
Oxford, OX3 7LE
Japan3 sites, 3 recruiting
- Recruiting
Research Site
Chūōku, 104-0045
- Recruiting
Research Site
Kashiwa, 227-8577
- Recruiting
Research Site
Sunto-gun, 411-8777
About this study
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
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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- Rilvegostomig, Volrustomig, FOLFOX, XELOX, AZD0901
- Keywords
- Locally advanced, Metatstatic, Gastric adenocarcinoma, GEJ adenocarcinoma, GEMINI-Gastric
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilvegostomigDrug
an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion
VolrustomigDrug
an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion
FOLFOXDrug
5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available)
XELOXDrug
capecitabine and oxaliplatin
AZD0901Drug
an anti Claudin18.2 ADC; IV infusion
5-FluorouracilDrug
5-FU, IV infusion
CapecitabineDrug
Oral take
| Study group | Role | What they receive |
|---|---|---|
| Substudy 1 | Experimental | Volrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF) Receives: Drug: Volrustomig; Drug: FOLFOX; Drug: XELOX |
| Substudy 2 | Experimental | Rilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF) Receives: Drug: Rilvegostomig; Drug: FOLFOX; Drug: XELOX |
| Substudy 3 | Experimental | AZD0901 plus volrustomig and 5-fluorouracil or capecitabine Receives: Drug: Volrustomig; Drug: AZD0901; Drug: 5-Fluorouracil; Drug: Capecitabine |
| Substudy 4, Cohort 4a1 | Experimental | Sonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil or capecitabine Receives: Drug: Rilvegostomig; Drug: AZD0901; Drug: 5-Fluorouracil; Drug: Capecitabine |
| Substudy 4, Cohort 4a2 | Experimental | Sonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil Receives: Drug: Rilvegostomig; Drug: AZD0901; Drug: 5-Fluorouracil |
| Substudy 4, Cohort 4b | Experimental | Sonesitatug vedotin (AZD0901) plus capecitabine Receives: Drug: AZD0901; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through substudy completion, an average of 2 years
Secondary outcomes (4)
PFS per RECIST 1.1 as assessed by the Investigator
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.
Measured: Through substudy completion, an average of 2 years
OS
the time from the start of study intervention until the date of death due to any cause.
Measured: Through substudy completion, an average of 2 years
other safety related endpoints
Incidence of AEs, AESIs, and SAEs.
Measured: Through substudy completion, an average of 2 years
DoR per RECIST 1.1 based on Investigator assessment.
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.
Measured: Through substudy completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start16 Jan 2023
- Primary completion30 Nov 2027 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702229
- Sponsor's protocol ID
- D7986C00001
- Other IDs
- 2024-510977-27-00, 2022-002840-29
- Status last verified
- May 2026
- First submitted
- 7 Dec 2022
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05702229
- Acronym / sponsor ID
- D7986C00001
- Conditions
- Gastric Cancer
- Keywords
- Locally advanced, Metatstatic, Gastric adenocarcinoma, GEJ adenocarcinoma, GEMINI-Gastric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Substudy 1 | Experimental | Drug: Volrustomig, Drug: FOLFOX, Drug: XELOXVolrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF) |
| Substudy 2 | Experimental | Drug: Rilvegostomig, Drug: FOLFOX, Drug: XELOXRilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF) |
| Substudy 3 | Experimental | Drug: Volrustomig, Drug: AZD0901, Drug: 5-Fluorouracil, Drug: CapecitabineAZD0901 plus volrustomig and 5-fluorouracil or capecitabine |
| Substudy 4, Cohort 4a1 | Experimental | Drug: Rilvegostomig, Drug: AZD0901, Drug: 5-Fluorouracil, Drug: CapecitabineSonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil or capecitabine |
| Substudy 4, Cohort 4a2 | Experimental | Drug: Rilvegostomig, Drug: AZD0901, Drug: 5-FluorouracilSonesitatug vedotin (AZD0901) plus rilvegostomig and 5-fluorouracil |
| Substudy 4, Cohort 4b | Experimental | Drug: AZD0901, Drug: CapecitabineSonesitatug vedotin (AZD0901) plus capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rilvegostomigan anti PD-1 and anti-TIGIT bispecific antibody; IV infusion | Drug | Substudy 2, Substudy 4, Cohort 4a1, Substudy 4, Cohort 4a2 |
| Volrustomigan anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion | Drug | Substudy 1, Substudy 3 |
| FOLFOX5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available) | Drug | Substudy 1, Substudy 2 |
| XELOXcapecitabine and oxaliplatin | Drug | Substudy 1, Substudy 2 |
| AZD0901an anti Claudin18.2 ADC; IV infusion | Drug | Substudy 3, Substudy 4, Cohort 4a1, Substudy 4, Cohort 4a2, Substudy 4, Cohort 4b |
| 5-Fluorouracil5-FU, IV infusion | Drug | Substudy 3, Substudy 4, Cohort 4a1, Substudy 4, Cohort 4a2 |
| CapecitabineOral take | Drug | Substudy 3, Substudy 4, Cohort 4a1, Substudy 4, Cohort 4b |
Primary outcome
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.
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
44 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rilvegostomig, Volrustomig and FOLFOX in people with Gastric Cancer, run by AstraZeneca at 44 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, China, Taiwan, Spain, South Korea and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (per RECIST 1.1 as assessed by Investigator) (time frame: Through substudy completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.