Clinical trial NCT05494762: Safety, Pharmacokinetics, and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab (BGB-A317) in Participants With Advanced Solid Tumors
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 Patients With Selected Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2022-08-10
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.


Eligibility criteria: 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.

Primary outcomes:
measure: Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to approximately 3 years
measure: Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)
timeFrame: Up to approximately 3 years
measure: Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
timeFrame: Up to approximately 3 years
measure: Phase 1a: Maximum tolerated dose (MTD)
timeFrame: Up to approximately 3 years
measure: Phase 1a: Recommended Phase 2 doses (RP2Ds)
timeFrame: Up to 90 days after the last dose of study drug(s); up to approximately 3 years
measure: Phase 1b: Objective Response Rate (ORR)
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Phase 1a: ORR
timeFrame: Up to approximately 3 years
measure: Phase 1a and 1b: Duration of Response (DOR)
timeFrame: Up to approximately 3 years
measure: Phase 1a and 1b: Disease Control Rate (DCR)
timeFrame: Up to approximately 3 years
measure: Phase 1a and 1b: Clinical Benefit Rate (CBR)
timeFrame: Up to approximately 3 years
measure: Phase 1b: Progression-free Survival (PFS)
timeFrame: Up to approximately 3 years
measure: Phase 1a and 1b: Serum Concentration of Tislelizumab
timeFrame: Up to approximately 3 years
measure: Phase 1a and 1b: Maximum observed serum concentration (Cmax) of BGB-B167
timeFrame: Up to approximately 3 years
measure: Phase 1a and 1b: Minimum observed serum concentration (Cmin) of BGB-B167
timeFrame: Up to approximately 3 years
measure: Phase 1a and 1b: Time to reach maximum observed serum concentration (Tmax) of BGB-B167
timeFrame: Up to approximately 3 years
measure: Phase 1a and 1b: Elimination half life (t1/2) of BGB-B167
timeFrame: Up to approximately 3 years
measure: Phase 1a and 1b: Area under the concentration-time curve in 1 dosing interval (AUCtau) of BGB-B167
timeFrame: Up to approximately 3 years
measure: Phase 1a and 1b: Total body clearance (CL) of BGB-B167
timeFrame: Up to approximately 3 years
measure: Phase 1a and 1b: Volume of distribution at steady state (Vss) of BGB-B167
timeFrame: Up to approximately 3 years
measure: Phase 1b: Number of Participants with AEs or SAEs
timeFrame: Up to approximately 3 years
measure: Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs)
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: New Haven
country: United States
facility: Yale University, Yale Cancer Center
state: Connecticut
city: Nashville
country: United States
facility: Tennessee Oncology, Pllc Nashville
state: Tennessee
city: Blacktown
country: Australia
facility: Blacktown Cancer and Haematology Centre
state: New South Wales
city: Kurralta Park
country: Australia
facility: Icon Cancer Centre Kurralta Park
state: South Australia
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter Maccallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: