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Sonrotoclax for

Phase 1

Healthy Volunteers | Small molecule | Other |BeOne Medicines Ltd.|Last Updated: Jul 9, 2026

Target and mechanism

ModalitySmall molecule

Also known as Sonrotoclax, sonrotoclax, Sonrotoclax Tablet for Oral Suspension

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

PRIORITY_REVIEW

Clinical trial landscape

Sonrotoclax for · 1 trial · 1 indication

Phase 1 1
NCT07628881A Study to Investigate the Relative Bioavailability and Food Effect of Tablet for Oral Suspension of Sonrotoclax in Healthy AdultsHealthy Volunteers
RECRUITING12 Analytics
PHASE1RECRUITING
A Study to Investigate the Relative Bioavailability and Food Effect of Tablet for Oral Suspension of Sonrotoclax in Healthy Adults
Healthy Volunteers
NCT0762888112
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Study Endpoints

Primary Endpoints

Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) for Sonrotoclax
Approximately 20 days
Area under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) for Sonrotoclax
Approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Sonrotoclax
Approximately 20 days

Secondary Endpoints

Time of the Maximum Observed Concentration (Tmax) for Sonrotoclax
Approximately 20 days
Apparent Terminal Elimination Half-life (t1/2) for Sonrotoclax
Approximately 20 days
Apparent Total Clearance (CL/F) for Sonrotoclax
Approximately 20 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sonrotoclax Tablet for Oral SuspensionEXPERIMENTALParticipants will receive each of the following treatments as a single dose on 3 separate occasions with an 8-day washout in between: 1. oral dose of sonrotoclax tablet for oral suspension administered in the fed state with a high-fat meal. 2. oral dose of sonrotoclax tablet for oral suspension administered after fasting 3. oral dose of sonrotoclax tablet administered in the fed state with a high-fat meal.

Interventions

NameTypeDescription
Sonrotoclax Tablet for Oral SuspensionDRUGAdministered orally
Sonrotoclax TabletDRUGAdministered orally
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Participants who are overtly healthy as determined by no clinica...

Countries:Australia
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Recent Changes (Last 90 Days)

LOWJul 9, 2026NCT07628881Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 9, 2026NCT07628881Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about Sonrotoclax for

What is Sonrotoclax used for?

Sonrotoclax is an investigational small molecule being studied in oncology. Clinical trials are evaluating it in relapsed/refractory multiple myeloma, chronic lymphocytic leukemia (CLL), acute myeloid leukemia, and Waldenstrom macroglobulinemia. It is also being studied in healthy volunteers for drug interaction effects. Sonrotoclax is not approved and remains in clinical development.

What does Sonrotoclax target?

Sonrotoclax is a small molecule oncology drug, but its specific molecular target is not disclosed in the available information. It is being studied across multiple hematologic malignancies, including multiple myeloma, CLL, and acute myeloid leukemia, as monotherapy and in combination with other agents.

Who is developing Sonrotoclax?

Sonrotoclax is being developed by BeOne Medicines Ltd., a company listed under the ticker ONC. The company is conducting multiple clinical trials of Sonrotoclax across various oncology indications, including a Phase 3 study in chronic lymphocytic leukemia.

What phase is Sonrotoclax in?

Sonrotoclax is in Phase 3 clinical development. The most advanced study is a Phase 3 trial in chronic lymphocytic leukemia comparing Sonrotoclax plus zanubrutinib against venetoclax plus obinutuzumab. Additional Phase 1 and Phase 2 trials are also active in other indications.

What clinical trials is Sonrotoclax in?

Sonrotoclax has four clinical trials. NCT06073821 is a Phase 3 study in CLL. NCT04973605 is a Phase 1b/2 study in relapsed/refractory multiple myeloma. NCT06497062 is a Phase 2 study in acute myeloid leukemia. NCT06543043 is a completed Phase 1 healthy volunteer drug interaction study.

Is Sonrotoclax the same as BGB-11417?

Sonrotoclax is also known as BGB-11417 in clinical trial documentation. Multiple trials reference Sonrotoclax (BGB-11417) in their titles, confirming these names refer to the same investigational drug. The drug is also referred to as Sonrotoclax Tablet for Oral Suspension.