Trial Title:
Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
NCT ID:
NCT05702229
Condition:
Gastric Cancer
Conditions: Official terms:
Adenocarcinoma
Capecitabine
Fluorouracil
Conditions: Keywords:
Locally advanced
Metatstatic
Gastric adenocarcinoma
GEJ adenocarcinoma
GEMINI-Gastric
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Rilvegostomig
Description:
an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion
Arm group label:
Substudy 2
Arm group label:
Substudy 4
Intervention type:
Drug
Intervention name:
Volrustomig
Description:
an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion
Arm group label:
Substudy 1
Arm group label:
Substudy 3
Intervention type:
Drug
Intervention name:
FOLFOX
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
Arm group label:
Substudy 1
Arm group label:
Substudy 2
Arm group label:
Substudy 5
Intervention type:
Drug
Intervention name:
XELOX
Description:
capecitabine 1000 mg/m^2 BID, days 1 to 14, oxaliplatin 130 mg/m^2, day 1
Arm group label:
Substudy 1
Arm group label:
Substudy 2
Arm group label:
Substudy 5
Intervention type:
Drug
Intervention name:
AZD7789
Description:
an anti PD 1 and anti TIM 3 bispecific antibody; IV infusion
Arm group label:
Substudy 5
Arm group label:
Substudy 6
Intervention type:
Drug
Intervention name:
AZD0901
Description:
an anti Claudin18.2 ADC; IV infusion
Arm group label:
Substudy 3
Arm group label:
Substudy 4
Arm group label:
Substudy 6
Intervention type:
Drug
Intervention name:
5-Fluorouracil
Description:
5-FU, IV infusion, Q3W
Arm group label:
Substudy 3
Arm group label:
Substudy 4
Arm group label:
Substudy 6
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Oral take, Q3W
Arm group label:
Substudy 3
Arm group label:
Substudy 4
Arm group label:
Substudy 6
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 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.
Criteria for 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 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
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.
- 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Los Angeles
Zip:
90017
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Baton Rouge
Zip:
70817
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bronx
Zip:
10469
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New Hyde Park
Zip:
11042
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New York
Zip:
10028
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New York
Zip:
11210
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shirley
Zip:
11967
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pittsburgh
Zip:
15212
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hangzhou
Zip:
310020
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hefei
Zip:
230031
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kunming
Zip:
650118
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Yinchuan
Zip:
750004
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kashiwa
Zip:
227-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tokyo
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Elche(Alicante)
Zip:
03202
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
L'Hospitalet de Llobregat
Zip:
08908
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hsinchu
Zip:
300
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kaohsiung
Zip:
80756
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taichung
Zip:
404
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tainan City
Zip:
70403
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
11259
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taoyuan City
Zip:
333
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Edinburgh
Zip:
EH4 2XU
Country:
United Kingdom
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Leeds
Zip:
LS9 7TF
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
EC1M 6BQ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Status:
Recruiting
Start date:
January 16, 2023
Completion date:
March 31, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05702229
