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NCT05644626
Safety, Pharmacokinetics and Antitumor Activity of BGB-B167alone and in Combination With Tislelizumab in Participants With Solid Tumors in Chinese Participants
Conditions: Solid Tumors
Sex: All
Ages: 18 Years – N/A
Phase: PHASE1
Enrollment: 254
Sponsor: BeiGene
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
Eligibility 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 investigatorEastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1Adequate 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 studyNonsterile men must be willing to use highly effective method of birth control for the duration of the studyExclusion Criteria:Active leptomeningeal disease or uncontrolled, untreated brain metastasisActive autoimmune diseases or history of autoimmune diseases that may relapseAny 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 intentHistory of severe hypersensitivity reactions to other monoclonal antibody products or their excipientsUntreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriersKnown history of HIV infection.
Source: ClinicalTrials.gov (NCT05644626). StuddyBuddy aggregates publicly available trial information.