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
BeOne Medicines
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 ≥ 7 days after the las…
Interventions
- DrugBGB-16673
Administered orally
- DrugSonrotoclax
Administered orally
- DrugZanubrutinib
Administered orally
- DrugMosunetuzumab
Administered subcutaneously
- DrugGlofitamab
Administered intravenously
- DrugObinutuzumab
Administered intravenously
Locations (50)
- Mayo Clinic PhoenixPhoenix, Arizona
- University of Southern Californianorris ComprehensiveLos Angeles, California
- Mayo Clinic JacksonvilleJacksonville, Florida
- Moffitt Cancer CenterTampa, Florida
- The University of Kansas Cancer CenterWestwood, Kansas
- Mayo Clinic RochesterRochester, Minnesota