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

Last updated: April 10, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

1

Condition

Metastatic Cancer

Neoplasm Metastasis

Neoplasms

Treatment

Chemotherapy

BGB-B3227

Tislelizumab

Clinical Study ID

NCT06540066
BGB-B3227-101
2024-514216-27-00
CTR20244018
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced or metastatic solidtumors 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

Exclusion Criteria:

  • History of prior ≥ Grade 3 Cytokine Release Syndrome (CRS)

  • History of severe Infusion-Related Reactions (IRRs), allergic reactions, orhypersensitivity to any ingredients or components of the study treatments

  • Infection requiring systemic (oral or intravenous) therapy ≤ 14 days before thefirst 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.

Study Design

Total Participants: 75
Treatment Group(s): 3
Primary Treatment: Chemotherapy
Phase: 1
Study Start date:
August 30, 2024
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milano, 20133
    Italy

    Active - Recruiting

  • Istituto Europeo Di Oncologia

    Milano, 20141
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Usc Norris Comprehensive Cancer Center (Nccc)

    Los Angeles, California 90089-1019
    United States

    Active - Recruiting

  • Washington University in St Louis

    Saint Louis, Missouri 63110-1010
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601-1915
    United States

    Active - Recruiting

  • Md Anderson Cancer Center

    Houston, Texas 77030-3907
    United States

    Active - Recruiting

  • Next Oncology

    San Antonio, Texas 78229-6028
    United States

    Active - Recruiting

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