Clinical Trial 23624

• Overview

  Study Title:

  A Phase 1/2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies

  Summary:

  The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.

  Objective:

  Primary Objectives: To evaluate the incidence of TLS in novel dosing/ramp-up schedules. Secondary Objectives: To evaluate the safety and tolerability of novel dosing/ramp-up schedules for sonrotoclax. To evaluate the impact of novel dosing/ramp-up schedules on treatment exposure.

• Treatments

  Therapies:

  BTK Inhibitor; Selective BCL-2 protein Inhibitor

  Medications:

  Sonrotoclax (); Zanubrutinib ()

• Inclusion Criteria

  Inclusion Criteria:
  • Stable ECOG Performance Status greater than or equal to 2.
  • Adequate organ function and no very recent transfusion or blood growth factor
  • 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 ≥ 90 days after the last dose of sonrotoclax or ≥ 30 days after the last dose of zanubrutinib, whichever is later.
  • Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease
  • At least 1 measurable lesion based on computed tomography (CT)/magnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • Participants unable to comply with the requirements of the protocol
  • Serologic status reflecting active viral HBV or HCV infection
  • Positive HIV serology (HIVAb) status unless certain conditions are met.
  • Participants with any major surgical procedure ≤ 28 days before first dose of study treatment
  • Prior systemic treatment for the CLL
  • Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
  • Other criteria may apply

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