A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
BeOne Medicines
Study ID
NCT06634589
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • B-cell Lymphoma
  • B-cell Malignancy
  • Refractory Cancer
  • Relapsed Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BGB-16673 — DRUG
    Administered orally
  • Sonrotoclax — DRUG
    Administered orally
  • Zanubrutinib — DRUG
    Administered orally
  • Mosunetuzumab — DRUG
    Administered subcutaneously
  • Glofitamab — DRUG
    Administered intravenously
  • Obinutuzumab — DRUG
    Administered intravenously

Study Details

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.

Key Dates

Start date
Nov 27, 2024
Status verified
Jun 2026
Primary completion
Dec 2, 2028
Completion
Dec 2, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Substudy 1 Part 1a: Dose Escalation
    Sequential cohorts of increasing dose level combinations of BGB-16673 and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
  • Experimental: Substudy 1 Part 1b: Safety Expansion
    Cohorts of select dose level combinations of BGB-16673 and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
  • Experimental: Substudy 2 Part 1a: Dose Escalation
    Sequential cohorts of increasing dose level combinations of BGB-16673 and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
  • Experimental: Substudy 2 Part 1b: Safety Expansion
    Cohorts of select dose level combinations of BGB-16673 and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
  • Experimental: Substudy 3 Part 1a: Dose Escalation
    Sequential cohorts of increasing dose level combinations of BGB-16673 and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
  • Experimental: Substudy 3 Part 1b: Safety Expansion
    Cohorts of select dose level combinations of BGB-16673 and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
  • Experimental: Substudy 4 Part 1a: Dose Escalation
    Sequential cohorts of increasing dose level combinations of BGB-16673 and glofitamab will be evaluated in participants with selected B-cell malignancies. Participants will receive obinutuzumab as pretreatment prior to the start of combination treatment.
  • Experimental: Substudy 4 Part 1b: Safety Expansion
    Cohorts of select dose level combinations of BGB-16673 and glofitamab will be evaluated in participants with selected B-cell malignancies.

Primary Outcome Measure

Substudy 1 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events [ Time Frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Mayo Clinic PhoenixPhoenixArizona85054-4502-
University of Southern California Norris ComprehensiveLos AngelesCalifornia90033-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-1865-
Moffitt Cancer CenterTampaFlorida33612-9496-
The University of Kansas Cancer CenterWestwoodKansas66205-2003-
Mayo Clinic RochesterRochesterMinnesota55905-0001-
Washington University School of MedicineSt LouisMissouri63110-1010-
Summit Medical GroupFlorham ParkNew Jersey07932-1049-
Columbia University Medical CenterNew YorkNew York10032-
Icahn School of Medicine At Mount SinaiNew YorkNew York10029-6504-
Memorial Sloan Kettering Cancer Center MskccNew YorkNew York10065-6800-
Weill Cornell Medical College Newyork Presbyterian HospitalNew YorkNew York10065-4870-
University of RochesterRochesterNew York14642-0001-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-2434-
The University of Texas Md Anderson Cancer CenterHoustonTexas77030-4009-
Huntsman Cancer InstituteSalt Lake CityUtah84112-5550-
University of WisconsinMadisonWisconsin53792-0001-
Medical College of WisconsinMilwaukeeWisconsin53226-1222-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Phoenix· Phoenix, AZUniversity of Southern California Norris Comprehensive· Los Angeles, CAMayo Clinic Jacksonville· Jacksonville, FLMoffitt Cancer Center· Tampa, FLThe University of Kansas Cancer Center· Westwood, KSMayo Clinic Rochester· Rochester, MN

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