Testing BGB-B3227 alone and with tislelizumab for advanced cancer
A Multicenter, Open-label, Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B3227 as Monotherapy and in Combination With Tislelizumab in Patients With Advanced or Metastatic Solid Tumors
This study is testing a new treatment called BGB-B3227, alone and with another drug, to see if it helps people with advanced cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BeiGene Industry-sponsored |
| Drugs / interventions | tislelizumab, chemotherapy |
| Locations | 12 sites (Los Angeles, California and 11 other locations) |
| Trial ID | NCT06540066 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, open-label, multicenter study evaluating the safety and effectiveness of BGB-B3227, a humanized antibody, in patients with advanced or metastatic solid tumors. The study will assess BGB-B3227 both as a standalone treatment and in combination with tislelizumab, with or without chemotherapy. It aims to determine the recommended doses for further testing and to gather data on pharmacokinetics and preliminary antitumor activity.
Who should consider this trial
Good fit: Ideal candidates include individuals with confirmed advanced or metastatic solid tumors that express mucin-1 (MUC1) and have at least one measurable lesion.
Not a fit: Patients with a history of severe cytokine release syndrome, active autoimmune diseases, or uncontrolled brain metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced or metastatic solid tumors.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California and 11 other locations
- Usc Norris Comprehensive Cancer Center (Nccc) — Los Angeles, California, United States (Recruiting)
- Washington University in St Louis — Saint Louis, Missouri, United States (Recruiting)
- Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
- Md Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Next Oncology — San Antonio, Texas, United States (Recruiting)
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)
- Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)
- Affiliated Zhongshan Hospital of Fudan University — Shanghai, Shanghai, China (Recruiting)
- Fondazione Irccs Istituto Nazionale Dei Tumori — Milano, Italy (Recruiting)
- Istituto Europeo Di Oncologia — Milano, Italy (Recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli — Roma, Italy (Recruiting)
- Istituto Clinico Humanitas — Rozzano, Italy (Recruiting)
Study contacts
- Study coordinator: Study Director
- Email: clinicaltrials@beigene.com
- Phone: 1.877.828.5568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.