RecruitingPhase 1Phase 2NCT06697184

A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.

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


Sponsor

BeOne Medicines

Enrollment

258 participants

Start Date

Jan 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria10

  • Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 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 ≥ 7 days after the last dose of sonrotoclax or 1 month after the last dose of zanubrutinib, whichever is later.
  • Only for participants with Chronic Lymphocytic Leukemia (CLL):
  • 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.
  • Only for participants with Mantle cell lymphoma (MCL):
  • Historically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HEAM5) or based on International Consensus Classification (ICC).
  • Relapsed or refractory to the last line of therapy and have received at least 1 prior line of systemic therapy. Note: A line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen. Patients with prior BTKi therapy should not have progressed during treatment or relapsed within 12 months after BTKi discontinuation.
  • Measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter.

Exclusion Criteria7

  • Participants unable to comply with the requirements of the protocol
  • Serologic status reflecting active viral hepatitis B virus (HBV) or hepatitis C virus (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
  • Prior exposure to a BCL-2 inhibitor

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Interventions

DRUGSonrotoclax

Administered orally

DRUGZanubrutinib

Administered orally


Locations(17)

Moffitt Cancer Center

Tampa, Florida, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

The University of Kansas Cancer Center

Westwood, Kansas, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

Genesiscare St Andrews

Adelaide, South Australia, Australia

Cabrini Hospital Malvern

Malvern, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Rockingham Hospital

Cooloongup, Western Australia, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

Chu Dijon

Dijon, France

Chu Montpellier Hopital Saint Eloi

Montpellier, France

Iuct Oncopole

Toulouse, France

Queen Elizabeth Hospital

Birmingham, United Kingdom

St Jamess University Hospital

Leeds, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06697184


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