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A Study of BGB-11417 in Participants With Myeloid Malignancies
RecruitingPhase 1/2
A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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) .
What is being tested
- BGB-11417 (drug)
- Azacitidine (drug)
- Posaconazole (drug)
- BGB-11417 (drug)
- BGB-11417 (drug)
Sponsor: BeOne Medicines · Participants: 260 · Started: May 24, 2021
Contact the study team
- Study Director · Phone: 1.877.828.5568
Official record on ClinicalTrials.gov — NCT04771130
Locations in the U.S.
| Florida | Tampa General Hospital, Tampa |
| Pennsylvania | Upmc Hillman Cancer Center(Univ of Pittsburgh), Pittsburgh |
| Texas | Md Anderson Cancer Center, Houston |
| Wisconsin | Medical College of Wisconsin, Milwaukee |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.