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

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD2936
MEDI5752
FOLFOX
XELOX
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Locally advanced, Metatstatic, Gastric adenocarcinoma, GEJ adenocarcinoma, GEMINI-Gastric

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 0 or 1. Life expectancy of at least 12 weeks. Adequate organ and bone marrow function. Exclusion Criteria: Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by ISH] 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 A/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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Substudy 1

Substudy 2

Arm Description

MEDI5752 Plus XELOX/FOLFOX

AZD2936 Plus XELOX/FOLFOX

Outcomes

Primary Outcome Measures

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.
PFS6 (per RECIST 1.1 as assessed by Investigator)
the proportion of participants alive and progression-free at 6 months.

Secondary Outcome Measures

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.
OS
the time from the start of study intervention until the date of death due to any cause.
other safety related endpoints
Incidence of AEs, AESIs, and SAEs

Full Information

First Posted
December 7, 2022
Last Updated
October 9, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT05702229
Brief Title
Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
August 15, 2025 (Anticipated)
Study Completion Date
February 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Approximately 80 participants will be assigned across two substudies, with approximately 40 evaluable participants for study intervention in each corresponding substudy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Locally advanced, Metatstatic, Gastric adenocarcinoma, GEJ adenocarcinoma, GEMINI-Gastric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Substudy 1
Arm Type
Experimental
Arm Description
MEDI5752 Plus XELOX/FOLFOX
Arm Title
Substudy 2
Arm Type
Experimental
Arm Description
AZD2936 Plus XELOX/FOLFOX
Intervention Type
Drug
Intervention Name(s)
AZD2936
Intervention Description
a PD-1 and TIGIT bispecific antibody; IV infusion
Intervention Type
Drug
Intervention Name(s)
MEDI5752
Intervention Description
a PD-1 and CTLA-4 bispecific antibody; IV infusion
Intervention Type
Drug
Intervention Name(s)
FOLFOX
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
XELOX
Intervention Description
capecitabine 1000 mg/m^2 BID, days 1 to 14, oxaliplatin 130 mg/m^2, day 1
Primary Outcome Measure Information:
Title
ORR (per RECIST 1.1 as assessed by Investigator)
Description
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.
Time Frame
Through study completion, an average of 2 years
Title
PFS6 (per RECIST 1.1 as assessed by Investigator)
Description
the proportion of participants alive and progression-free at 6 months.
Time Frame
Through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
PFS per RECIST 1.1 as assessed by the Investigator
Description
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.
Time Frame
Through study completion, an average of 2 years
Title
OS
Description
the time from the start of study intervention until the date of death due to any cause.
Time Frame
Through study completion, an average of 2 years
Title
other safety related endpoints
Description
Incidence of AEs, AESIs, and SAEs
Time Frame
Through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 0 or 1. Life expectancy of at least 12 weeks. Adequate organ and bone marrow function. Exclusion Criteria: Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by ISH] 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 A/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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70817
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10469
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
11210
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310020
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230031
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yinchuan
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kashiwa
ZIP/Postal Code
227-8577
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Elche(Alicante)
ZIP/Postal Code
03202
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tainan City
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11259
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

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

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