A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

Part of paid clinical trials in Duarte, California.

Sponsor
BeOne Medicines
Study ID
NCT05952037
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Waldenstrom Macroglobulinemia
  • Waldenstrom's Macroglobulinemia Recurrent
  • Waldenstrom's Macroglobulinemia Refractory

Eligibility Criteria

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

Interventions

  • Sonrotoclax — DRUG
    Administered orally as a tablet.
  • Zanubrutinib — DRUG
    Administered orally as a capsule.

Study Details

This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.

Key Dates

Start date
Oct 23, 2023
Status verified
Dec 2025
Primary completion
Sep 22, 2026
Completion
Aug 31, 2028

Study Design

Enrollment
114 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Participants with R/R disease to both Bruton tyrosine kinase (BTK) inhibitor and anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor will receive sonrotoclax at a standard dose, given orally once daily.
  • Experimental: Cohort 2
    Participants with R/R disease to anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor and were intolerant to BTK inhibitor will receive sonrotoclax at a standard dose, given orally once daily.
  • Experimental: Cohort 3
    Participants with R/R disease to a BTK inhibitor treatment and are unsuitable for chemoimmunotherapy will receive sonrotoclax at a standard dose, given orally once daily.
  • Experimental: Cohort 4
    Participants with previously untreated WM will receive sonrotoclax and zanubrutinib combination therapy for a fixed duration.

Primary Outcome Measure

Cohort 1: Major Response Rate (MRR) [ Time Frame: Up to approximately 4 years ]

Locations (17)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-3012-
Colorado Blood Cancer InstituteDenverColorado80218-
Medstar Georgetown University HospitalWashington D.C.District of Columbia20007-2113-
University of MiamiMiamiFlorida33136-2107-
Northwestern Medicine Cancer CenterWarrenvilleIllinois60555-3269-
Mission Cancer and BloodWaukeeIowa50263-
University of Maryland Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-1544-
Dana Farber Cancer InstituteBostonMassachusetts02215-5418-
Mayo Clinic RochesterRochesterMinnesota55905-0001-
Hattiesburg Hematology and Oncology ClinicHattiesburgMississippi39401-7233-
Memorial Sloan Kettering Cancer Center MskccNew YorkNew York10065-6800-
Atrium Health Levine Cancer Institute (Lci)CharlotteNorth Carolina28204-2990-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-1280-
Ut Southwestern Medical CenterDallasTexas75390-7208-
Huntsman Cancer InstituteSalt Lake CityUtah84112-5550-
Virginia Commonwealth University Massey Cancer CenterRichmondVirginia23298-
University of WashingtonSeattleWashington98195-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAColorado Blood Cancer Institute· Denver, COMedstar Georgetown University Hospital· Washington D.C., DCUniversity of Miami· Miami, FLNorthwestern Medicine Cancer Center· Warrenville, ILMission Cancer and Blood· Waukee, IA

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