A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B167, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors

  • STATUS
    Recruiting
  • End date
    Aug 5, 2025
  • participants needed
    254
  • sponsor
    BeiGene
Updated on 11 October 2022

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.

Details
Condition Solid Tumor
Treatment tislelizumab, BGB-B167
Clinical Study IdentifierNCT05494762
SponsorBeiGene
Last Modified on11 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

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