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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Sonrotoclax

    Drug

    Administered orally

  • Zanubrutinib

    Drug

    Administered orally

Treatment groups

258 Participants
are divided into 2 treatment groups
Group A: Arms: 1A,1B and 2A: Zanubrutinib + Sonrotoclax for TN CLLExperimental treatment 2 interventions
Group B: Arms: 1C and 2B: Zanubrutinib + Sonrotoclax for R/R MCLExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants who Experience Tumor Lysis Syndrome (TLS)

TLS will be defined by Howard criteria during the schedule-limiting toxicity (SLT) evaluation window

Time frame
Up to approximately 4 months

Secondary outcomes

1

Number of Participants with Adverse Events (AEs)

Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 and tolerability as determined by protocol-defined Cs during the SLT evaluation window

Time frame
Up to approximately 4 months
2

Number of Participants with Dose Modifications During the SLT Evaluation Window

Time frame
Up to approximately 4 months

Other outcomes

Sponsors and contacts

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