Clinical trial NCT05644626: Safety, Pharmacokinetics and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab in Participants With Solid Tumors in Chinese Participants
Official title: 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 Chinese Patients With Selected Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Approximately 30 months
measure: Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
timeFrame: Up to Approximately 24 months
measure: Phase 1a: Maximum Tolerated Dose (MTD) of BGB-B167
timeFrame: Approximately 30 months
measure: Phase 1a: Recommended Phase 2 doses (RP2Ds)
timeFrame: Approximately 24 months
measure: Phase 1b: Objective Response Rate (ORR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Up to Approximately 30 months
Secondary outcomes:
measure: Phase 1a: ORR
timeFrame: Up to Approximately 30 months
measure: Phase 1a and Phase 1b: Duration of Response (DOR) as determined by investigators per RECIST v1.1.
timeFrame: Up to Approximately 30 months
measure: Phase 1a and Phase 1b: Disease Control Rate (DCR) as determined by investigators per RECIST v1.1.
timeFrame: Up to Approximately 30 months
measure: Phase 1a and Phase 1b: Clinical Benefit Rate (CBR) as determined by investigators per RECIST v1.1.
timeFrame: Up to Approximately 30 months
measure: Phase 1b: Progression Free Survival (PFS) as determined by investigators per RECIST v1.1.
timeFrame: Up to Approximately 30 months
measure: Phase 1a and Phase 1b: Maximum Serum Concentration (Cmax) of BGB-B167
timeFrame: Up to Approximately 30 months
measure: Phase 1a and Phase 1b: Minimum Observed Plasma Concentration (Cmin) of BGB-B167
timeFrame: Up to Approximately 30 months
measure: Phase 1a and Phase 1b: Time to Cmax (Tmax) of BGB-B167
timeFrame: Up to Approximately 30 months
measure: Phase 1a: Terminal half-life (t1/2) of BGB-B167
timeFrame: Up to Approximately 30 months
measure: Phase 1a: Area Under the Plasma Concentration-time curve (AUC0-7d) of BGB-B167
timeFrame: Up to Approximately 30 months
measure: Phase 1a: Clearance (CL) BGB-B167
timeFrame: Up to Approximately 30 months
measure: Phase 1a: Volume of Distribution at Steady State (Vss) of BGB-B167
timeFrame: Up to Approximately 30 months
measure: Phase 1a and Phase 1b: Number of Participants with Anti-Drug Antibodies (ADAs)
timeFrame: Up to Approximately 30 months
measure: Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Approximately 30 months
Other outcomes:
Locations:
Study officials:
References: