Clinical trial · Interventional
A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BGB-B3227 | Drug | — | UNRESOLVED |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase 1a Part A: Dose Escalation (BGB-B3227 Monotherapy)
- description
- Sequential cohorts of increasing dose levels of BGB-B3227 will be evaluated as monotherapy.
- interventionNames
- Drug: BGB-B3227
- type
- EXPERIMENTAL
- label
- Phase 1a Part B: Dose Escalation (BGB-B3227 + tislelizumab)
- description
- Sequential cohorts of increasing dose levels of BGB-B3227 will be evaluated in combination with tislelizumab.
- interventionNames
- Drug: BGB-B3227
- Drug: Tislelizumab
- type
- EXPERIMENTAL
- label
- Phase 1b: Dose Expansion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available