Overview

Safety, Pharmacokinetics and Antitumor Activity of BGB-B167alone and in Combination With Tislelizumab in Participants With Solid Tumors in Chinese Participants

Status:
Not yet recruiting
Trial end date:
2025-08-01
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BGB-B167 monotherapy and in combination with tislelizumab (BGB-A317) in participants with select advanced solid tumors in Chinese participants
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
BeiGene
Criteria
Inclusion Criteria:

- Participants with histologically or cytologically confirmed unresectable locally
advanced or metastatic solid tumors previously treated with standard systemic therapy
or for whom treatment is not available, not tolerated, or refused, or not expected to
provide significant clinical benefit or be tolerated in the medical judgement of the
investigator

- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1

- Adequate organ function as indicated by laboratory values during screening or ≤ 7 days
before the first dose of study drug(s)

- Women of childbearing potential must be willing to use a highly effective method of
birth control for the duration of the study

- Nonsterile men must be willing to use highly effective method of birth control for the
duration of the study

Exclusion Criteria:

- Active leptomeningeal disease or uncontrolled, untreated brain metastasis

- Active autoimmune diseases or history of autoimmune diseases that may relapse

- Any malignancy ≤ 3 years before the first dose of study drug(s) except for the
specific cancer under investigation in this study and any locally recurring cancer
that has been treated with curative intent

- History of severe hypersensitivity reactions to other monoclonal antibody products or
their excipients

- Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers

- Known history of HIV infection.