Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies

Conditions

• Mature B-Cell Malignancies

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sonrotoclax — DRUG
  Film-coated tablets administered once daily at a dose as specified in the treatment arm
• Zanubrutinib — DRUG
  320 mg daily administered as two 80-mg capsules twice a day (160 mg twice a day) or as four 80-mg capsules once a day (320 mg once a day)
• Obinutuzumab — DRUG
  Given as an intravenous infusion administered per label.

Study Details

The purpose of this study is to determine the safety, tolerability; and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib and obinutuzumab.

Key Dates

Start date

Mar 24, 2020

Status verified

May 2026

Primary completion

May 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

437 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sonrotoclax Monotherapy Dose Finding: Part 1
  Participants with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL) including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL) or transformed NHL, mantle cell lymphoma (MCL); Waldenströms macroglobulinemia (WM); and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) will receive oral sonrotoclax evaluated as monotherapy.
• Experimental: Sonrotoclax Monotherapy Expansion Cohorts: Part 2
  Participants with R/R indolent NHL including FL, MZL; aggressive NHL including DLBCL, transformed NHL; CLL/SLL with low tumor burden or low creatine clearance; CLL/SLL with without high tumor burden or low creatine clearance will receive oral sonrotoclax at the RP2D dose to further define the safety profile.
• Experimental: Sonrotoclax + Zanubrutinib Combination Therapy Dose Finding: Part 3
  Participants with R/R MCL, R/R or treatment-naïve (TN) CLL/SLL will receive oral sonrotoclax in combination with zanubrutinib.
• Experimental: Sonrotoclax + Zanubrutinib Combination Therapy Dose Expansion: Part 4
  Participants with R/R indolent NHL including FL, MZL; aggressive NHL including DLBCL, transformed NHL; R/R MCL; R/R or treatment-naïve (TN) CLL/SLL will receive oral sonrotoclax in combination with zanubrutinib at an RP2D dose to further define the safety profile.
• Experimental: Sonrotoclax + Zanubrutinib Combination Therapy Dose Escalation: Part 5
  Participants with treatment naïve CLL/SLL will receive oral sonrotoclax in combination with obinutuzumab without and with zanubrutinib.
• Experimental: Sonrotoclax + Zanubrutinib Combination Therapy Dose Expansion: Part 6
  Participants with treatment naïve CLL/SLL will receive oral sonrotoclax in combination with obinutuzumab without and with zanubrutinib at an RP2D dose to further define the safety profile.

Primary Outcome Measure

Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 30 days after the last dose of study drug, an average of 18 months ]

Locations (13)

Find similar trials in Los Angeles, CA

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