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

NCT05494762 | Terminated Phase 1 FDA Drug

• 1 other identifier: BGB-A317-B167-101
• Study Type: interventional
• Target: 55
• Locations: 2 countries
• Sites: 8

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (15)

• Phase 1a: ORR

  Up to approximately 3 years

• Phase 1a and 1b: Duration of Response (DOR)

  Up to approximately 3 years

• Phase 1a and 1b: Disease Control Rate (DCR)

  Up to approximately 3 years

• Phase 1a and 1b: Clinical Benefit Rate (CBR)

  Up to approximately 3 years

• Phase 1b: Progression-free Survival (PFS)

  Up to approximately 3 years

Study Arms (2)

Phase 1a: Dose Escalation

EXPERIMENTAL

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; Drug: Tislelizumab

Phase 1b: Dose Expansion

EXPERIMENTAL

BGB-B167 alone or in combination with tislelizumab (BGB-A317)

Drug: BGB-B167; Drug: Tislelizumab

Interventions

BGB-B167 DRUG

Intravenous administration

Phase 1a: Dose Escalation; Phase 1b: Dose Expansion

Tislelizumab DRUG

Intravenous administration

Also known as: BGB-A317

Phase 1a: Dose Escalation; Phase 1b: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BeiGene: lead

Study Sites (8)

City of Hope National Medical Center

Duarte, California, 91010-3012, United States

Location

Yale University, Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Tennessee Oncology, Pllc Nashville

Nashville, Tennessee, 37203-1619, United States

Location

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, 2148, Australia

Location

Icon Cancer Centre Kurralta Park

Kurralta Park, South Australia, 5037, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Peter Maccallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Interventions

tislelizumab

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: August 25, 2022
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (3); AU (5)