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Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIM-3 Monoclonal Antibody BGB-A425 in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid Tumors

Clinical Trial Details

This clinical trial is for men and women with advanced solid tumors, such as advanced head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC).
The purpose of this study is to learn about the safety and effectiveness of combining two investigational anti-cancer drugs, tislelizumab (also known as BGB-A317) and BGB-A425. Investigational means that these drugs have not yet been approved by the U.S. Food and Drug Administration (FDA). 

Tislelizumab and BGB-A425 are both monoclonal antibodies. An antibody is a common type of protein found in your body, through which the immune system finds and destroys bacteria, viruses, and other foreign molecules. Antibodies can also be produced in the laboratory and used for the treatment of patients. Tislelizumab affects cells in your immune system, making them more likely to attack cancer cells.

This study aims to determine the safe dose range of BGB-A425 that can be used in combination with a single standard dose of tislelizumab, what the side effects are when taking these drugs together, how the body copes with these drugs, and if these drugs shrink tumors.
This study has two parts, referred to as phases, and this participation is for phase 2 of the study. In phase 2, participants will be given BGB-A425 and tislelizumab at doses that were deemed to be well tolerated in Phase 1. Both drugs are given through an infusion into a vein in the arm. 

Tumor imaging will be performed approximately every 6 weeks throughout the first year of the study and approximately every 12 weeks after that. Study treatment may continue as long as there is no worsening of the disease or intolerable side effects from the study treatment.

Key Eligibility: 
  • Men and women aged 18 and older.
  • Confirmed advanced or metastatic, unresectable solid tumors (HNSCC, NSCLC, or RCC).
  • Have received 1 or 2 lines of prior systemic therapy that includes an anti-PD-1/PDL1 antibody in the most recent line of treatment.

Detailed eligibility reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan


Carina Puello, RN
(646) 962-3541

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:






Open to Enrollment

Age Group