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

BeiGene

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Solid Tumors

Interventions

BGB-B167DRUG

Intravenous administration

TislelizumabDRUG

Intravenous administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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 * Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers * Known history of HIV infection.

Outcomes

Primary Outcomes

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

Time frame: Up to Approximately 30 months

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

Time frame: 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%.

Time frame: 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

Time frame: 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).

Time frame: Up to Approximately 30 months

Secondary Outcomes

Phase 1a: ORR

ORR is defined as the proportion of participants who had confirmed complete response (CR) or partial response (PR) as determined by investigators per RECIST v1.1.

Time frame: Up to Approximately 30 months

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

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.