Recruiting
Phase 1
Phase 2

BGB-11417

Sponsor:

BeOne Medicines

Code:

NCT04771130

Conditions

Acute Myeloid Leukemia

Myelodysplastic Syndromes

Myelodysplastic/Myeloproliferative Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BGB-11417

Azacitidine

Posaconazole

BGB-11417

BGB-11417

Study Details

Brief summary:

The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN) .

Conditions

Acute Myeloid Leukemia

Myelodysplastic Syndromes

Myelodysplastic/Myeloproliferative Neoplasm

Study ID

NCT04771130

Start date

May 24, 2021

Status verified date

Sep, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:

  • AML, nonacute promyelocytic leukemia
  • MDS
  • MDS/MPN
2. Eastern Cooperative Oncology Group performance status of 0 to 2.
3. Adequate organ function defined as:

  • Creatinine clearance ≥ 50 milliliters/minute (mL/min) (or between 30 and 49 mL/min in unfit AML cohort)
  • Adequate liver function
4. Life expectancy of > 12 weeks.
5. Ability to comply with the requirements of the study.

Key Exclusion Criteria:

1. A diagnosis of acute promyelocytic leukemia.
2. History of prior malignancy, with the exception of either a history of MDS or MDS/MPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)
3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
4. Prior therapy with a B-cell lymphoma-2 inhibitor
5. Known central nervous system involvement by leukemia.

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

Study Design

Enrollment

260 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Parts 1 and 2: AML Cohorts

Participants with AML will receive BGB-11417 and azacitidine on a 28-day cycle.

experimental: Parts 1 and 2: MDS Cohorts

Participants with MDS will receive BGB-11417 and azacitidine on a 28-day cycle.

experimental: Part 3: AML and MDS Cohorts

Participants with AML and MDS will receive BGB-11417 and azacitidine on a 28-day cycle. A subset of the participants will receive a modified second cycle of treatment to explore drug-drug interactions (DDI) with posaconazole.

experimental: Part 3: AML and MDS Cohort

Participants with MDS and R/R AML (China only) will receive BGB-11417 on a 28-day cycle.

Interventions

BGB-11417

Oral administration for 10, 21, 14 or 28 days on a 28-day cycle.

Azacitidine

Intravenous or subcutaneous administration for 7 days.

Posaconazole

Oral administration for 8 days on second cycle only.

BGB-11417

Oral administration for 28 days on a 28-day cycle.

BGB-11417

Oral administration for 10, 14 or 21 days on a 28-day

Primary outcome measure

  • Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs) [ Time Frame: 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) [ Time Frame: Approximately 24 months ]
  • Part 3 AML Cohort: Complete Remission (CR) Plus CR With Partial Hematologic Recovery (CRh) Rate [ Time Frame: Approximately 24 months ]
  • Part 3 MDS Cohort: Modified Overall Response (mOR) Rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Cycle 2 ]
  • Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number of Participants Experiencing TEAEs [ Time Frame: Approximately 24 months ]

Central Contacts and Locations

Central contacts

Study Director

1.877.828.5568clinicaltrials@beonemed.com

Locations

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606-3571

Upmc Hillman Cancer Center(Univ of Pittsburgh)

Recruiting

Pittsburgh, Pennsylvania, United States, 15232-1309

Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-3907

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226-3522

More Information

Sponsor

BeOne Medicines

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • BGB-11417
  • Azacitidine
  • Posaconazole
  • AML
  • MDS
  • MDS/MPN

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-09-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.