Status:
RECRUITING
A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors
Lead Sponsor:
BeiGene
Conditions:
Advanced Cancer
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 sa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06540066
Start Date
August 30 2024
End Date
January 31 2027
Last Update
November 20 2025
Active Locations (12)
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1
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, United States, 90089-1019
2
Washington University in St Louis
St Louis, Missouri, United States, 63110-1010
3
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601-1915
4
Next Oncology
Austin, Texas, United States, 78758