Trials / Recruiting
RecruitingNCT06634589
A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- BeOne Medicines · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This new study will check how safe and helpful a potential anticancer drug called BGB-16673 is in participants with R/R B-cell malignancies when it is given in combination with other medicines - sonrotoclax in substudy 1, zanubrutinib in substudy 2, mosunetuzumab in substudy 3, and glofitamab in substudy 4. Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BGB-16673 | Administered orally |
| DRUG | Sonrotoclax | Administered orally |
| DRUG | Zanubrutinib | Administered orally |
| DRUG | Mosunetuzumab | Administered subcutaneously |
| DRUG | Glofitamab | Administered intravenously |
| DRUG | Obinutuzumab | Administered intravenously |
Timeline
- Start date
- 2024-11-27
- Primary completion
- 2028-12-02
- Completion
- 2029-12-02
- First posted
- 2024-10-10
- Last updated
- 2026-04-15
Locations
50 sites across 8 countries: United States, Australia, Brazil, China, Germany, Italy, New Zealand, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06634589. Inclusion in this directory is not an endorsement.