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

NCT03736889 | Recruiting Phase 2

• 2 other identifiers: BGB-A317-209CTR20180867
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 29

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).

Conditions

MSI-H/dMMR Solid Tumors

Keywords

MSI-H/dMMR; Solid tumors; PD-1

Outcome Measures

Primary Outcomes (1)

• Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1

  Up to 2 years

Secondary Outcomes (7)

• 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

• 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

• Overall survival

  Up to 2 years

Study Arms (1)

Tislelizumab (BGB-A317) Injection

EXPERIMENTAL

Drug: Tislelizumab (BGB-A317)

Interventions

Tislelizumab (BGB-A317) DRUG

Anti-PD-1 Antibody

Tislelizumab (BGB-A317) Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having histological confirmed diagnosis of malignancy
• Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR
• Having received prior cancer therapy regimen(s) for advanced disease.
• At least 1 measurable lesion as defined per RECIST Version (v) 1.1
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
• Adequate organ function

You may not qualify if:

• 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
• Active leptomeningeal disease or uncontrolled brain metastasis.
• Clinically significant pleural effusion, pericardial effusion or ascites
• Active autoimmune diseases or history of autoimmune diseases that may relapse
• Any active malignancy
• 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
• 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.)
• Participants with uncontrolled diabetes or uncontrolled electrolyte disorders despite standard medical management
• Having severe chronic or active infections
• A known history of human immunodeficiency virus infection
• Child - Pugh B or greater cirrhosis
• Any major surgical procedure ≤ 28 days before the first dose of study drug
• Prior allogeneic stem cell transplantation or organ transplantation

Sponsors & Collaborators

• BeiGene: lead

Study Sites (29)

Anhui Provincial Hospital

Hefei, Anhui, 230000, China

COMPLETED

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

COMPLETED

The Affiliated Hospital of Military Medical Sciences

Beijing, Beijing Municipality, 100071, China

COMPLETED

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, 510080, China

COMPLETED

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

COMPLETED

The Sixth Affiliated Hospital, Sun Yat Sen University

Guangzhou, Guangdong, 510655, China

COMPLETED

Huizhou First Hospital

Huizhou, Guangdong, 516000, China

RECRUITING

Meizhou People Hospital

Meizhou, Guangdong, 514031, China

RECRUITING

The Peoples Hospital of Hechi

Hechi, Guangxi, 547099, China

RECRUITING

Affiliated Hospital of Hebei University

Baoding, Hebei, 071000, China

COMPLETED

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

COMPLETED

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

COMPLETED

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

COMPLETED

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

COMPLETED

Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

COMPLETED

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

COMPLETED

Jilin Cancer Hospital

Changchun, Jilin, 130021, China

COMPLETED

The General Hospital of Shenyang Military

Shenyang, Liaoning, 110016, China

COMPLETED

Yidu Central Hospital of Weifang

Weifang, Shandong, 262550, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

COMPLETED

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

COMPLETED

The First Peoples Hospital of Yibin

Yibin, Sichuan, 644000, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

COMPLETED

Zhejiang University College of Medicine Second Affiliated Hospital

Hangzhou, Zhejiang, 310009, China

COMPLETED

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

COMPLETED

MeSH Terms

Interventions

tislelizumab

Study Officials

• Lin Shen, PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BeiGene

CONTACT

+1-877-828-5568; clinicaltrials@beigene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 9, 2018
• Study Start: September 19, 2018
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CN (29)