A Study of BGB-11417 in Participants With Myeloid Malignancies
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) .
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:
- AML, nonacute promyelocytic leukemia
- MDS
- MDS/MPN
- Eastern Cooperative Oncology Group performance status of 0 to 2.
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
- Life expectancy of > 12 weeks.
- Ability to comply with the requirements of the study.
EXCLUSION CRITERIA
Key Exclusion Criteria:
- A diagnosis of acute promyelocytic leukemia.
- Prior malignancy within the past 2 years, except for curatively treated localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer.
- Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
- Prior therapy with a B-cell lymphoma-2 inhibitor or azacitidine except for participants who meet HMA-failure criteria
- Known central nervous system involvement by leukemia.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Acute Myeloid Leukemia,Myelodysplastic Syndromes,Myelodysplastic/Myeloproliferative Neoplasm
Age (in years)
18+
Phase
Phase 1/Phase 2
Participants needed
260
Est. Completion Date
Aug 31, 2025
Treatment type
Interventional
Sponsor
BeiGene
ClinicalTrials.gov identifier
NCT04771130
Study number
BGB-11417-103
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