Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors

Phase 2

Recruiting

• Conditions: MSI-H/dMMR Solid Tumors
• Interventions: Drug: Tislelizumab (BGB-A317)

• Registration Number: NCT03736889
• Lead Sponsor: BeiGene

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-19
• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06
• Primary Completion: 2026-11
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tislelizumab (BGB-A317) Injection	Tislelizumab (BGB-A317)	-

Primary Outcome Measures

Name	Time	Method
Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
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
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
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
Overall survival	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

Trial Locations

Locations (29)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

The Affiliated Hospital of Military Medical Sciences; 🇨🇳 Beijing, Beijing, China

Guangdong Provincial Peoples Hospital; 🇨🇳 Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

The Sixth Affiliated Hospital, Sun Yat Sen University; 🇨🇳 Guangzhou, Guangdong, China

The Peoples Hospital of Hechi; 🇨🇳 Hechi, Guangxi, China

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Hubei Cancer Hospital; 🇨🇳 Wuhan, Hubei, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China

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