Safety, Pharmacokinetics and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab in Participants With Solid Tumors in Chinese Participants

NCT05644626 | Withdrawn Phase 1

• 1 other identifier: BGB-A317-B167-102
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (5)

• Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to Approximately 30 months

• Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria

  Up to Approximately 24 months

• Phase 1a: Maximum Tolerated Dose (MTD) of BGB-B167

  The maximum tolerated dose (MTD) is defined as the highest tolerated dose for which the estimated toxicity rate is closest to the target toxicity rate of 30%.

  Approximately 30 months

• 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

  Approximately 24 months

• Phase 1b: Objective Response Rate (ORR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  ORR is defined as the proportion of participants who had confirmed complete response (CR) or partial response (PR).

  Up to Approximately 30 months

Secondary Outcomes (14)

• Phase 1a: ORR

  Up to Approximately 30 months

• Phase 1a and Phase 1b: Duration of Response (DOR) as determined by investigators per RECIST v1.1.

  Up to Approximately 30 months

• Phase 1a and Phase 1b: Disease Control Rate (DCR) as determined by investigators per RECIST v1.1.

  Up to Approximately 30 months

• Phase 1a and Phase 1b: Clinical Benefit Rate (CBR) as determined by investigators per RECIST v1.1.

  Up to Approximately 30 months

• Phase 1b: Progression Free Survival (PFS) as determined by investigators per RECIST v1.1.

  Up to Approximately 30 months

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:

• 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

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
• Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers
• Known history of HIV infection.

Sponsors & Collaborators

• BeiGene: lead

MeSH Terms

Interventions

tislelizumab

Study Design

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

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11