A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors

BeiGene

Status and phase: Enrolling; Phase 1

Conditions: Metastatic Cancer; Advanced Cancer; Advanced Solid Tumor; Metastatic Solid Tumor

Treatments: Drug: Tislelizumab; Drug: Chemotherapy; Drug: BGB-B3227

Study type: Interventional

Funder types: Industry

Identifiers

NCT06540066

BGB-B3227-101

CTR20244018 (Registry Identifier)

2024-514216-27-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of BGB-B3227, a humanized immunoglobulin G1 (IgG1) antibody. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-B3227 as a monotherapy or in combination with tislelizumab with or without chemotherapy in participants with selected advanced or metastatic solid tumors. The study will also identify recommended dose(s) for expansion (RDFE[s]) of BGB-B3227 administered alone and in combination with tislelizumab.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed locally advanced or metastatic solid tumors with a high prevalence of mucin-1 (MUC1) expression
• At least 1 measurable lesion per RECIST v1.1
• Stable Eastern Cooperative Oncology Group Performance Status of ≤ 1
• Adequate organ function
• Willing to use a highly effective method of birth control

Exclusion criteria

• History of prior ≥ Grade 3 Cytokine Release Syndrome (CRS)
• History of severe Infusion-Related Reactions (IRRs), allergic reactions, or hypersensitivity to any ingredients or components of the study treatments
• Infection requiring systemic (oral or intravenous) therapy ≤ 14 days before the first dose of study drug(s), or participants with symptomatic COVID-19 infection
• Active leptomeningeal disease or uncontrolled, untreated brain metastasis
• Active autoimmune disease or history of autoimmune disease(s) that may relapse

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Phase 1a Part A: Dose Escalation (BGB-B3227 Monotherapy)

Experimental group

Description:

Sequential cohorts of increasing dose levels of BGB-B3227 will be evaluated as monotherapy.

Treatment:

Drug: BGB-B3227

Phase 1a Part B: Dose Escalation (BGB-B3227 + tislelizumab)

Experimental group

Description:

Sequential cohorts of increasing dose levels of BGB-B3227 will be evaluated in combination with tislelizumab.

Treatment:

Drug: BGB-B3227

Drug: Tislelizumab

Phase 1b: Dose Expansion

Experimental group

Description:

Sequential cohorts of increasing dose levels of BGB-B3227 will be evaluated in combination with tislelizumab and chemotherapy.

Treatment:

Drug: BGB-B3227

Drug: Chemotherapy

Drug: Tislelizumab