NCT06634589 A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
| NCT ID | NCT06634589 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | BeOne Medicines |
| Condition | B-cell Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-11-27 |
| Primary Completion | 2028-12-02 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with BGB-16673 in combination with other agents in participants with relapsed or refractory (R/R) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study currently includes four substudies, and more substudies may be added as other combination agents are identified.
Eligibility Criteria
Key Inclusion Criteria: * Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF * Confirmed diagnosis of a R/R B-cell malignancy * Protocol-defined measurable disease * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 * Adequate organ function * Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of sonrotoclax or mosunetuzumab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment * Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the dura