Treatment of advanced solid tumors with Tislelizumab

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

This study is testing if Tislelizumab can help people with advanced solid tumors that are hard to treat due to certain genetic features feel better and improve their health after other treatments have failed.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BeOne Medicines (Industry-sponsored)
• Drugs / interventions: prednisone, Tislelizumab
• Locations: 29 sites (Hefei, Anhui and 28 other locations)
• Trial ID: NCT03736889 on ClinicalTrials.gov

What this trial studies

This Phase 2, single-arm, multi-center, open-label study aims to evaluate the efficacy of Tislelizumab, an anti-PD-1 monoclonal antibody, in patients with locally advanced unresectable or metastatic solid tumors characterized by microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR). Participants must have previously received cancer therapies and have at least one measurable lesion. The study will assess the treatment's impact on tumor response and overall patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced solid tumors that are MSI-H or dMMR and have previously undergone cancer treatment.

Not a fit: Patients with active autoimmune diseases, prior treatment with PD-1 inhibitors, or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat solid tumors.

How similar studies have performed: Previous studies have shown promising results with PD-1 inhibitors in similar patient populations, indicating potential for success.

Eligibility 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/Exclusion criteria may apply.

Where this trial is running

Hefei, Anhui and 28 other locations

• Anhui Provincial Hospital — Hefei, Anhui, China (Completed)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Completed)
• The Affiliated Hospital of Military Medical Sciences — Beijing, Beijing Municipality, China (Completed)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
• Guangdong Provincial Peoples Hospital — Guangzhou, Guangdong, China (Completed)
• Nanfang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Completed)
• The Sixth Affiliated Hospital, Sun Yat Sen University — Guangzhou, Guangdong, China (Completed)
• Huizhou First Hospital — Huizhou, Guangdong, China (Recruiting)
• Meizhou People Hospital — Meizhou, Guangdong, China (Recruiting)
• The Peoples Hospital of Hechi — Hechi, Guangxi, China (Recruiting)
• Affiliated Hospital of Hebei University — Baoding, Hebei, China (Completed)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Completed)
• Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Completed)
• Hubei Cancer Hospital — Wuhan, Hubei, China (Completed)
• Hunan Cancer Hospital — Changsha, Hunan, China (Completed)
• Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Completed)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Completed)
• Jilin Cancer Hospital — Changchun, Jilin, China (Completed)
• The General Hospital of Shenyang Military — Shenyang, Liaoning, China (Completed)
• Yidu Central Hospital of Weifang — Weifang, Shandong, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Completed)
• Affiliated Zhongshan Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Completed)
• The First Peoples Hospital of Yibin — Yibin, Sichuan, China (Recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Completed)
• Zhejiang University College of Medicine Second Affiliated Hospital — Hangzhou, Zhejiang, China (Completed)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Completed)

Study contacts

• Principal investigator: Lin Shen, PhD — Peking University Cancer Hospital & Institute
• Study coordinator: BeiGene

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