Gastric Cancer
Conditions
Keywords
Locally advanced, Metatstatic, Gastric adenocarcinoma, GEJ adenocarcinoma, GEMINI-Gastric
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 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.
Interventions
DRUGRilvegostomig
an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion
DRUGVolrustomig
an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion
DRUGFOLFOX
5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available)
DRUGXELOX
capecitabine and oxaliplatin
DRUGAZD0901
an anti Claudin18.2 ADC; IV infusion
DRUG5-Fluorouracil
5-FU, IV infusion
DRUGCapecitabine
Oral take
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 i s 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 is open for recruitment).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR (per RECIST 1.1 as assessed by Investigator) | 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) | Through substudy completion, an average of 2 years | the proportion of participants alive and progression-free at 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS per RECIST 1.1 as assessed by the Investigator | 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 | 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 | Through substudy completion, an average of 2 years | Incidence of AEs, AESIs, and SAEs. |
| DoR per RECIST 1.1 based on Investigator assessment. | 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. |
Countries
China, Japan, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed