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

Stopped early · Phase 1

Conditions studied: Advanced Cancer, Advanced Solid Tumor, Metastatic Cancer, Metastatic Solid Tumor

In brief

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.

Key facts

Study ID

NCT06540066

Run by

BeiGene

People needed

35

Starts

2024-09-11

Expected to finish

2026-01-09

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Usc Norris Comprehensive Cancer Center (Nccc) — Los Angeles, California, United States
• Washington University in St Louis — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Next Oncology — Austin, Texas, United States
• Md Anderson Cancer Center — Houston, Texas, United States
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China
• Affiliated Zhongshan Hospital of Fudan University — Shanghai, Shanghai Municipality, China
• Fondazione Irccs Istituto Nazionale Dei Tumori — Milan, Italy
• Istituto Europeo Di Oncologia — Milan, Italy
• Fondazione Policlinico Universitario Agostino Gemelli — Roma, Italy
• Istituto Clinico Humanitas — Rozzano, Italy

Full record on ClinicalTrials.gov

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