Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
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ClinicalTrials.gov Identifier: NCT05702229 |
Recruitment Status :
Recruiting
First Posted : January 27, 2023
Last Update Posted : April 23, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Cancer | Drug: Rilvegostomig Drug: Volrustomig Drug: FOLFOX Drug: XELOX Drug: AZD7789 Drug: AZD0901 Drug: 5-Fluorouracil Drug: Capecitabine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | January 16, 2023 |
Estimated Primary Completion Date : | September 30, 2025 |
Estimated Study Completion Date : | March 31, 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Substudy 1
Volrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
|
Drug: Volrustomig
an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion Drug: FOLFOX 5-fluorouracil 400 mg/m^2 IV, oxaliplatin 85 mg/m^2, leucovorin 400 mg/m^2 (or levoleucovorin 200 mg/m^2 when locally preferred and available), day 1, 5-fluorouracil 1200 mg/m^2 IV 24 h day 1-2 Drug: XELOX capecitabine 1000 mg/m^2 BID, days 1 to 14, oxaliplatin 130 mg/m^2, day 1 |
Experimental: Substudy 2
Rilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
|
Drug: Rilvegostomig
an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion Drug: FOLFOX 5-fluorouracil 400 mg/m^2 IV, oxaliplatin 85 mg/m^2, leucovorin 400 mg/m^2 (or levoleucovorin 200 mg/m^2 when locally preferred and available), day 1, 5-fluorouracil 1200 mg/m^2 IV 24 h day 1-2 Drug: XELOX capecitabine 1000 mg/m^2 BID, days 1 to 14, oxaliplatin 130 mg/m^2, day 1 |
Experimental: Substudy 3
AZD0901 plus volrustomig and 5-fluorouracil or capecitabine
|
Drug: Volrustomig
an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion Drug: AZD0901 an anti Claudin18.2 ADC; IV infusion Drug: 5-Fluorouracil 5-FU, IV infusion, Q3W Drug: Capecitabine Oral take, Q3W |
Experimental: Substudy 4
AZD0901 plus rilvegostomig and 5-fluorouracil or capecitabine
|
Drug: Rilvegostomig
an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion Drug: AZD0901 an anti Claudin18.2 ADC; IV infusion Drug: 5-Fluorouracil 5-FU, IV infusion, Q3W Drug: Capecitabine Oral take, Q3W |
Experimental: Substudy 5
AZD7789 plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
|
Drug: FOLFOX
5-fluorouracil 400 mg/m^2 IV, oxaliplatin 85 mg/m^2, leucovorin 400 mg/m^2 (or levoleucovorin 200 mg/m^2 when locally preferred and available), day 1, 5-fluorouracil 1200 mg/m^2 IV 24 h day 1-2 Drug: XELOX capecitabine 1000 mg/m^2 BID, days 1 to 14, oxaliplatin 130 mg/m^2, day 1 Drug: AZD7789 an anti PD 1 and anti TIM 3 bispecific antibody; IV infusion |
Experimental: Substudy 6
AZD0901 plus AZD7789 and 5-fluorouracil or capecitabine
|
Drug: AZD7789
an anti PD 1 and anti TIM 3 bispecific antibody; IV infusion Drug: AZD0901 an anti Claudin18.2 ADC; IV infusion Drug: 5-Fluorouracil 5-FU, IV infusion, Q3W Drug: Capecitabine Oral take, Q3W |
- 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.
- 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.
- 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.
- other safety related endpoints [ Time Frame: Through substudy completion, an average of 2 years ]Incidence of AEs, AESIs, and SAEs.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 or Substudy 6 is 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, or Substudy 6 is open for recruitment).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05702229
Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
United States, California | |
Research Site | Recruiting |
Los Angeles, California, United States, 90017 | |
Research Site | Withdrawn |
Los Angeles, California, United States, 90095 | |
United States, Louisiana | |
Research Site | Recruiting |
Baton Rouge, Louisiana, United States, 70817 | |
United States, Michigan | |
Research Site | Recruiting |
Grand Rapids, Michigan, United States, 49503 | |
United States, New York | |
Research Site | Recruiting |
Bronx, New York, United States, 10469 | |
Research Site | Recruiting |
New Hyde Park, New York, United States, 11042 | |
Research Site | Recruiting |
New York, New York, United States, 10028 | |
Research Site | Recruiting |
New York, New York, United States, 11210 | |
Research Site | Recruiting |
Shirley, New York, United States, 11967 | |
United States, Pennsylvania | |
Research Site | Recruiting |
Pittsburgh, Pennsylvania, United States, 15212 | |
China | |
Research Site | Recruiting |
Beijing, China, 100142 | |
Research Site | Recruiting |
Hangzhou, China, 310003 | |
Research Site | Recruiting |
Hangzhou, China, 310020 | |
Research Site | Recruiting |
Harbin, China, 150081 | |
Research Site | Recruiting |
Hefei, China, 230031 | |
Research Site | Not yet recruiting |
Kunming, China, 650118 | |
Research Site | Recruiting |
Wuhan, China, 430079 | |
Research Site | Recruiting |
Yinchuan, China, 750004 | |
Research Site | Recruiting |
Zhengzhou, China | |
Japan | |
Research Site | Recruiting |
Kashiwa, Japan, 227-8577 | |
Research Site | Recruiting |
Sunto-gun, Japan, 411-8777 | |
Research Site | Recruiting |
Tokyo, Japan, 104-0045 | |
Korea, Republic of | |
Research Site | Recruiting |
Seoul, Korea, Republic of, 03080 | |
Research Site | Recruiting |
Seoul, Korea, Republic of, 03722 | |
Research Site | Recruiting |
Seoul, Korea, Republic of, 05505 | |
Research Site | Recruiting |
Seoul, Korea, Republic of, 06351 | |
Spain | |
Research Site | Recruiting |
Barcelona, Spain, 08035 | |
Research Site | Recruiting |
Elche(Alicante), Spain, 03202 | |
Research Site | Recruiting |
L'Hospitalet de Llobregat, Spain, 08908 | |
Research Site | Recruiting |
Madrid, Spain, 28007 | |
Research Site | Recruiting |
Madrid, Spain, 28040 | |
Research Site | Recruiting |
Santander, Spain, 39008 | |
Taiwan | |
Research Site | Recruiting |
Hsinchu, Taiwan, 300 | |
Research Site | Recruiting |
Kaohsiung, Taiwan, 80756 | |
Research Site | Recruiting |
Taichung, Taiwan, 404 | |
Research Site | Recruiting |
Tainan City, Taiwan, 70403 | |
Research Site | Recruiting |
Taipei, Taiwan, 10002 | |
Research Site | Recruiting |
Taipei, Taiwan, 11259 | |
Research Site | Recruiting |
Taoyuan City, Taiwan, 333 | |
United Kingdom | |
Research Site | Suspended |
Edinburgh, United Kingdom, EH4 2XU | |
Research Site | Recruiting |
Leeds, United Kingdom, LS9 7TF | |
Research Site | Not yet recruiting |
London, United Kingdom, EC1M 6BQ | |
Research Site | Recruiting |
Oxford, United Kingdom, OX3 7LE |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT05702229 |
Other Study ID Numbers: |
D7986C00001 2022-002840-29 ( EudraCT Number ) |
First Posted: | January 27, 2023 Key Record Dates |
Last Update Posted: | April 23, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
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. |
URL: | https://astrazenecagroup-dt.pharmacm.com/DT/Home |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Locally advanced Metatstatic Gastric adenocarcinoma GEJ adenocarcinoma GEMINI-Gastric |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Capecitabine Fluorouracil |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |