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

NCT ID: NCT05644626

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2025-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

BGB-B167

Intervention Type DRUG

Intravenous administration

Tislelizumab

Intervention Type DRUG

Intravenous administration

Phase 1b: Dose Expansion

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

Group Type EXPERIMENTAL

BGB-B167

Intervention Type DRUG

Intravenous administration

Tislelizumab

Intervention Type DRUG

Intravenous administration

Interventions

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BGB-B167

Intravenous administration

Intervention Type DRUG

Tislelizumab

Intravenous administration

Intervention Type DRUG

Other Intervention Names

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BGB-A317

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BeiGene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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BGB-A317-B167-102

Identifier Type: -

Identifier Source: org_study_id