Investigating a new dosing schedule for sonrotoclax in blood cancer treatment

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

This study is testing new ways to give the drug sonrotoclax to see if it can safely help people with chronic lymphocytic leukemia (CLL) feel better.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BeiGene (industry)
• Drugs / interventions: zanubrutinib
• Locations: 20 sites (Tampa, Florida and 19 other locations)
• Trial ID: NCT06697184 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety of novel dosing and ramp-up schedules for the experimental drug sonrotoclax in patients with chronic lymphocytic leukemia (CLL). The approach involves gradually increasing the dose of sonrotoclax over specified periods to reach the target daily dose while monitoring for tumor lysis syndrome and related toxicities. Initially, small groups of participants will test each dosing schedule for safety, followed by a larger group to further assess the approved schedules. The goal is to optimize the dosing regimen to enhance patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults with a confirmed diagnosis of CLL who require treatment and have stable organ function.

Not a fit: Patients with active viral infections or those unable to comply with the study protocol may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer and more effective treatment options for patients with chronic lymphocytic leukemia.

How similar studies have performed: Other studies have explored dosing schedules for similar treatments, but this specific approach with sonrotoclax is novel.

Eligibility criteria

Inclusion Criteria:

1. Stable ECOG Performance Status ≤ 2.
2. Adequate organ function and no very recent transfusion or blood growth factor
3. 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.
4. Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease
5. At least 1 measurable lesion based on computed tomography (CT)/magnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.

Exclusion Criteria:

1. Participants unable to comply with the requirements of the protocol
2. Serologic status reflecting active viral HBV or HCV infection
3. Positive HIV serology (HIVAb) status unless certain conditions are met.
4. Participants with any major surgical procedure ≤ 28 days before first dose of study treatment
5. Prior systemic treatment for the CLL
6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Tampa, Florida and 19 other locations

• Moffitt Cancer Center — Tampa, Florida, United States (NOT_YET_RECRUITING)
• Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States (NOT_YET_RECRUITING)
• The University of Kansas Cancer Center — Westwood, Kansas, United States (NOT_YET_RECRUITING)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
• Washington University School of Medicine — Saint Louis, Missouri, United States (NOT_YET_RECRUITING)
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States (NOT_YET_RECRUITING)
• Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia (RECRUITING)
• Cabrini Hospital Malvern — Malvern East, Victoria, Australia (NOT_YET_RECRUITING)
• The Alfred Hospital — Melbourne, Victoria, Australia (RECRUITING)
• Rockingham Hospital — Cooloongup, Western Australia, Australia (RECRUITING)
• Linear Clinical Research — Nedlands, Western Australia, Australia (RECRUITING)
• Hopital Avicenne, Aphp, Bobigny — Bobigny, France (NOT_YET_RECRUITING)
• Chu Dijon — Dijon, France (NOT_YET_RECRUITING)
• Chu Montpellier Hopital Saint Eloi — Montpellier, France (NOT_YET_RECRUITING)
• Hopital Larchet Chu Nice — Nice, France (NOT_YET_RECRUITING)
• Iuct Oncopole — Toulouse, France (NOT_YET_RECRUITING)
• Queen Elizabeth Hospital — Birmingham, United Kingdom (NOT_YET_RECRUITING)
• University Hospitals Bristol and Weston Nhs Foundation Trust — Bristol, United Kingdom (NOT_YET_RECRUITING)
• St Jamess University Hospital — Leeds, United Kingdom (NOT_YET_RECRUITING)
• The Christie Nhs Foundation Trust Manchester — Manchester, United Kingdom (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Study Director

Conditions: Chronic Lymphocytic Leukemia, CLL, CLL previously untreated, Hematological Malignancies