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Evaluating BGB-11417 for treating myeloid malignancies

A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies

Phase1; Phase2 Interventional BeOne Medicines · NCT04771130

This study is testing a new drug called BGB-11417, alone and with another medication, to see if it can safely help people with acute myeloid leukemia and myelodysplastic syndromes.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment260 (estimated)
Ages18 Years and up
SexAll
SponsorBeOne Medicines Industry-sponsored
Locations46 sites (Duarte, California and 45 other locations)
Trial IDNCT04771130 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and effectiveness of BGB-11417, both alone and in combination with azacitidine, in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). It aims to establish the recommended Phase 2 dose and assess preliminary efficacy. Participants will be monitored for tolerability and organ function throughout the trial. The study is designed to provide insights into new treatment options for these serious blood disorders.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with AML, MDS, or MDS/MPN who meet specific health criteria.

Not a fit: Patients with acute promyelocytic leukemia or those with a history of certain prior malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with myeloid malignancies, potentially improving outcomes.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Duarte, California and 45 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmBGB-11417AzacitidinePosaconazoleAMLMDS
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.