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Trial record 1 of 1 for:    D7986C00001
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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 : March 26, 2024
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

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

Detailed Description:
Approximately 240 participants will be assigned across 6 substudies, with approximately 40 evaluable participants of the confirmed recommend dose by SRC for study intervention in each corresponding substudy.

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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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. other safety related endpoints [ Time Frame: Through substudy completion, an average of 2 years ]
    Incidence of AEs, AESIs, and SAEs.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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).

Information from the National Library of Medicine

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


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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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 Not yet 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
Sponsors and Collaborators
AstraZeneca
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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: March 26, 2024
Last Verified: March 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Locally advanced
Metatstatic
Gastric adenocarcinoma
GEJ adenocarcinoma
GEMINI-Gastric
Additional relevant MeSH terms:
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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