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

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

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.

Study Overview

• Status: Terminated
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: BGB-B167; Drug: Tislelizumab

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Blacktown Cancer and Haematology Centre
  • South Australia
    • Kurralta Park, South Australia, Australia, 5037
      • Icon Cancer Centre Kurralta Park
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre
• United States
  • California
    • Duarte, California, United States, 91010-3012
      • City of Hope National Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520-8028
      • Yale University, Yale Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203-1619
      • Tennessee Oncology, Pllc Nashville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1a: Dose Escalation; Part A: Increasing dose levels of BGB-B167 monotherapy; Part B: Increasing dose levels of BGB-B167 in combination with tislelizumab (BGB-A317)	Drug: BGB-B167; Intravenous administration; Drug: Tislelizumab; Intravenous administration; Other Names: BGB-A317
Experimental: Phase 1b: Dose Expansion; BGB-B167 alone or in combination with tislelizumab (BGB-A317)	Drug: BGB-B167; Intravenous administration; Drug: Tislelizumab; Intravenous administration; Other Names: BGB-A317

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)		Up to approximately 3 years
Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)		Up to approximately 3 years
Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria		Up to approximately 3 years
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Phase 1a and 1b: Serum Concentration of Tislelizumab		Up to approximately 3 years
Phase 1a and 1b: Maximum observed serum concentration (Cmax) of BGB-B167		Up to approximately 3 years
Phase 1a and 1b: Minimum observed serum concentration (Cmin) of BGB-B167		Up to approximately 3 years
Phase 1a and 1b: Time to reach maximum observed serum concentration (Tmax) of BGB-B167		Up to approximately 3 years
Phase 1a and 1b: Elimination half life (t1/2) of BGB-B167		Up to approximately 3 years
Phase 1a and 1b: Area under the concentration-time curve in 1 dosing interval (AUCtau) of BGB-B167		Up to approximately 3 years
Phase 1a and 1b: Total body clearance (CL) of BGB-B167		Up to approximately 3 years
Phase 1a and 1b: Volume of distribution at steady state (Vss) of BGB-B167		Up to approximately 3 years
Phase 1b: Number of Participants with AEs or SAEs		Up to approximately 3 years
Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs)		Up to approximately 3 years

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: Study Director, BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2022
• Primary Completion (Actual): February 24, 2025
• Study Completion (Actual): February 24, 2025

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Tislelizumab
• Other Study ID Numbers: BGB-A317-B167-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No