MSI-H/dMMR Solid Tumors Clinical Trial
Official title:
A Single-Arm, Multi-Center, Open-Label, Phase 2 Study to Evaluate Efficacy and Safety of Tislelizumab (BGB-A317), an Anti-PD-1 Monoclonal Antibody, as Monotherapy in Patients With Previously-Treated Locally Advanced Unresectable or Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors
| Verified date | January 2024 |
| Source | BeiGene |
| Contact | BeiGene |
| Phone | +1-877-828-5568 |
| clinicaltrials[@]beigene.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | September 2027 |
| Est. primary completion date | November 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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/Exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| China | Affiliated Hospital of Hebei University | Baoding | Hebei |
| China | Beijing Cancer Hospital | Beijing | Beijing |
| China | Jilin Cancer Hospital | Changchun | Jilin |
| China | Chongqing Cancer Hospital | Chongqing | Chongqing |
| China | Fujian Medical University Union Hospital | Fuzhou | Fujian |
| China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
| China | Zhejiang University College of Medicine Second Affiliated Hospital | Hangzhou | Zhejiang |
| China | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang |
| China | Anhui Provincial Hospital | Hefei | Anhui |
| China | Meizhou People Hospital | Meizhou | Guangdong |
| China | Affiliated Zhongshan Hospital of Fudan University | Shanghai | Shanghai |
| China | Henan Cancer Hospital | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| BeiGene |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to 2 years | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | Overall survival | Up to 2 years | ||
| Secondary | Objective response rate assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | Up to 2 years | ||
| Secondary | 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 |