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

BeiGene

Status and phase: Terminated; Phase 1

Conditions: Solid Tumor

Treatments: Drug: Tislelizumab; Drug: BGB-B167

Study type: Interventional

Funder types: Industry

Identifiers

NCT05494762

BGB-A317-B167-101

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Phase 1a: Dose Escalation

Experimental group

Description:

Part A: Increasing dose levels of BGB-B167 monotherapy; Part B: Increasing dose levels of BGB-B167 in combination with tislelizumab (BGB-A317)

Treatment:

Drug: BGB-B167

Drug: Tislelizumab

Phase 1b: Dose Expansion

Experimental group

Description:

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

Treatment:

Drug: BGB-B167

Drug: Tislelizumab