A Study of BGB-11417 in Participants With Myeloid Malignancies

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NCT04771130 · readout in 538 d

Sponsored by BeOne Medicines (industry) · ONC — their whole pipeline →.

Phase

Phase 1/2

Status

Recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

260estimated

Sites

Countries

Australia, China, France +7

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2021-05-24

actual

When the study began enrolling

Primary completion

2028-02-08

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2028-02-08

estimated

The whole study's end, after follow-up

First posted

2021-02-25

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-13

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasm

Interventions

Drug: BGB-11417 — also filed as Sonrotoclax
Drug: Azacitidine
Drug: Posaconazole
Drug: BGB-11417
Drug: BGB-11417

Primary outcomes

what the primary-completion date above is the date OF

Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)

measured Cycle 1 (Up to 28 days for non-hematologic DLTs and up to 42 days for hematologic DLTs)

Part 1 And 2: Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

measured Approximately 24 months

Part 3 AML Cohort: Complete Remission (CR) Plus CR With Partial Hematologic Recovery (CRh) Rate

measured Approximately 24 months

Part 3 MDS Cohort: Modified Overall Response (mOR) Rate

measured Approximately 24 months

Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to the last quantifiable timepoint (t) (AUC0-t) Of BGB-11417 When Administered Alone and when Co-administered With Posaconazole

measured Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)

Part 3 AML Cohort (DDI Sub-cohort): Maximum Observed Plasma Concentration (Cmax) Of BGB-11417 When Administered Alone and When Co-administered With Posaconazole

measured Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)

Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to infinity (AUC0-infinity) Of BGB-11417 When Administered Alone and When Co-administered With Posaconazole

measured Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, , 4, 6, 8, and 24 hours postdose)

Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number Of Participants Experiencing DLTs

measured Cycle 2

Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number of Participants Experiencing TEAEs

measured Approximately 24 months

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