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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05494762
• Other study ID #: BGB-A317-B167-101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 25, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• BGB-B167
Intravenous administration
• Tislelizumab
Intravenous administration

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1a: Number of Participants Experiencing Adverse Events (AEs)		Up to approximately 3 years
Primary	Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)		Up to approximately 3 years
Primary	Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria		Up to approximately 3 years
Primary	Phase 1a: Maximum tolerated dose (MTD)	MTD is defined as the highest tolerated dose with the target toxicity rate of 30%	Up to approximately 3 years
Primary	Phase 1a: Recommended Phase 2 doses (RP2Ds)	RP2Ds of BGB-B167 alone or in combination with tislelizumab will be determined based on a biologically effective dose	Up to 90 days after the last dose of study drug(s); up to approximately 3 years
Primary	Phase 1b: Objective Response Rate (ORR)	ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Up to approximately 3 years
Secondary	Phase 1a: ORR	ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined by investigators per RECIST v1.1	Up to approximately 3 years
Secondary	Phase 1a and 1b: Duration of Response (DOR)	DOR is defined as the time from the first determination of a confirmed objective response until the first documentation of progression or death due to any cause, whichever occurs first, as determined by investigators per RECIST v1.1	Up to approximately 3 years
Secondary	Phase 1a and 1b: Disease Control Rate (DCR)	DCR is defined as the percentage of participants with best overall response (BOR) of confirmed CR, PR, or stable disease, as determined by investigators per RECIST v1.1	Up to approximately 3 years
Secondary	Phase 1a and 1b: Clinical Benefit Rate (CBR)	CBR is defined as the percentage of patients with best overall response of confirmed CR, PR, or stable disease lasting = 24 weeks, as determined by investigators per RECIST v1.1	Up to approximately 3 years
Secondary	Phase 1b: Progression-free Survival (PFS)	PFS is defined as the time from the date of the first administration of study drug to the date of the first documentation of disease progression or death due to any cause, whichever occurs first, as determined by investigators per RECIST v1.1	Up to approximately 3 years
Secondary	Phase 1a and 1b: Serum Concentration of Tislelizumab		Up to approximately 3 years
Secondary	Phase 1a and 1b: Maximum observed serum concentration (Cmax) of BGB-B167		Up to approximately 3 years
Secondary	Phase 1a and 1b: Minimum observed serum concentration (Cmin) of BGB-B167		Up to approximately 3 years
Secondary	Phase 1a and 1b: Time to reach maximum observed serum concentration (Tmax) of BGB-B167		Up to approximately 3 years
Secondary	Phase 1a and 1b: Elimination half life (t1/2) of BGB-B167		Up to approximately 3 years
Secondary	Phase 1a and 1b: Area under the concentration-time curve in 1 dosing interval (AUCtau) of BGB-B167		Up to approximately 3 years
Secondary	Phase 1a and 1b: Total body clearance (CL) of BGB-B167		Up to approximately 3 years
Secondary	Phase 1a and 1b: Volume of distribution at steady state (Vss) of BGB-B167		Up to approximately 3 years
Secondary	Phase 1b: Number of Participants with AEs or SAEs		Up to approximately 3 years
Secondary	Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs)		Up to approximately 3 years