Status:
COMPLETED
An Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Gastric and Gastroesophageal Junction Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced gastric carcinoma (GC) or gastroesophageal junction carcinoma (GEJC). The study is designed with...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Stage 1:
- ECOG Performance Status of 0 or 1
- Inoperable locally advanced, metastatic, or advanced GC or GEJC, with adenocarcinoma confirmed as the predominant histology
- No prior systemic treatment for advanced or metastatic disease
- Life expectancy \>= 3 months, as determined by the investigator
- Human epidermal growth factor receptor 2 (HER2)-negative tumors
- Measurable disease according to RECIST v1.1
- Adequate hematologic and end-organ function
- Patients without hepatitis B virus (HBV) infection at screening
- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- Negative HIV test at screening
- For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs, as outlined for each specific treatment arm
- For men: agreement to remain abstinent or use contraception, and agreement to refrain from donating sperm, as outlined for each specific treatment arm
- Exclusion Criteria for Stage 1:
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Any contraindications to any of the study drugs of the chemotherapy regimen
- Eligible only for the control arm
- Patients with a signet ring cells dominant carcinoma
- Symptomatic, untreated, or actively progressing CNS metastases
- History of leptomeningeal disease
- Active or history of autoimmune disease or immune deficiency
- Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
- History of malignancy other than GC or GEJC within 2 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death
- Exclusion Criteria for Tiragolumab-Containing Arm:
- Prior treatment with an anti-TIGIT agent
- Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
Exclusion
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05251948
Start Date
March 1 2022
End Date
September 4 2025
Last Update
October 14 2025
Active Locations (12)
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1
The General Hospital of People?s Liberation Army (301 Hospital)
Beijing, China, 100080
2
the First Hospital of Jilin University
Changchun, China, 130021
3
First Affiliated Hospital of Gannan Medical University
Ganzhou, China, 341000
4
The First Affiliated Hospital, Zhejiang University
Hangzhou, China, 310003