MSI-H/dMMR Solid Tumors
Conditions
Keywords
MSI-H/dMMR, Solid tumors, PD-1
Brief summary
In this Phase 2, Single-Arm, Multi-Center, Open-Label Study, participants with previously treated locally advanced unresectable or metastatic solid tumors with mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) will be treated with anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317).
Interventions
Anti-PD-1 Antibody
Sponsors
BeiGene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Having histological confirmed diagnosis of malignancy 2. Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR 3. Having received prior cancer therapy regimen(s) for advanced disease. 4. At least 1 measurable lesion as defined per RECIST Version (v) 1.1 5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 6. Adequate organ function Key
Exclusion criteria
1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 2. Active leptomeningeal disease or uncontrolled brain metastasis. 3. Clinically significant pleural effusion, pericardial effusion or ascites 4. Active autoimmune diseases or history of autoimmune diseases that may relapse 5. Any active malignancy 6. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug 7. Having a history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases, or uncontrolled systemic diseases (including but not limited to diabetes, hypertension, etc.) 8. Participants with uncontrolled diabetes or uncontrolled electrolyte disorders despite standard medical management 9. Having severe chronic or active infections 10. A known history of human immunodeficiency virus infection 11. Child - Pugh B or greater cirrhosis 12. Any major surgical procedure ≤ 28 days before the first dose of study drug 13. Prior allogeneic stem cell transplantation or organ transplantation NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Time to response assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to 2 years |
| Progression-free survival assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to 2 years |
| Disease control rate assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to 2 years |
| Duration of response assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to 2 years |
| Objective response rate assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to 2 years |
| Safety and tolerability assessment per the number of participants experiencing Treatment-Emergent Adverse Event (TEAE) as assessed by CTCAE v5.0 | Up to 2 years |
| Overall survival | Up to 2 years |
Countries
China
Contacts
Primary ContactBeiGene
Outcome results
None listed