Safety, Pharmacokinetics, and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab (BGB-A317) in Participants With Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT05494762

Run by

BeiGene

People needed

55

Starts

2022-08-25

Expected to finish

2025-02-24

Last updated by the study team

2025-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older
• 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)

You may not qualify if…

• 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
• Women who are pregnant or are breastfeeding
• NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Yale University, Yale Cancer Center — New Haven, Connecticut, United States
• Tennessee Oncology, Pllc Nashville — Nashville, Tennessee, United States
• Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia
• Icon Cancer Centre Kurralta Park — Kurralta Park, South Australia, Australia
• Monash Health — Clayton, Victoria, Australia
• Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

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