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NCT Number: NCT04771130

A Study of BGB-11417 in Participants With Myeloid Malignancies

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) .

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Key information

Conditions

Acute Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myelodysplastic/Myeloproliferative Neoplasm Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Concord Repatriation General Hospital, Concord, New South Wales, Australia

Loading trial locations.

About this study

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Key Exclusion Criteria:

  • A diagnosis of acute promyelocytic leukemia.
  • 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)
  • 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
  • Known central nervous system involvement by leukemia.

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

Treatment and study plan

BGB-11417

Drug

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

Other names: Sonrotoclax

Azacitidine

Drug

Intravenous or subcutaneous administration for 7 days.

Posaconazole

Drug

Oral administration for 8 days on second cycle only.

Primary outcomes

  1. 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)

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

    Time frame: Approximately 24 months

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

    Time frame: Approximately 24 months

    CR plus CRh will be defined as the percentage of participants whose best overall response (BOR) is CR plus CRh. BOR will be defined as the best response recorded from the first dose of study drug until data cut or the initiation of new anticancer treatment.

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

    Time frame: Approximately 24 months

    The mOR will be defined as the percentage of participants whose BOR is achieving CR, marrow complete remission (mCR), or partial remission (PR) at any time point during the study for myelodysplastic/myeloproliferative neoplasm (MDS/MPN).

  5. 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)

  6. 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)

  7. 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)

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

    Time frame: Cycle 2

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

    Time frame: Approximately 24 months

Secondary outcomes

  1. Parts 1 And 2 AML Cohort: Complete remission (CR) + Morphologic CR With Partial Hematologic Recovery (CRh)

    Time frame: Approximately 24 months

  2. Parts 1 And 2 MDS Cohort: mOR Rate

    Time frame: Approximately 24 months

  3. Parts 1 And 2: Cmax Of Azacitidine When Coadministered With BGB-11417

    Time frame: Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose

  4. Parts 1 And 2: Terminal Half-life (t1/2) Of Azacitidine When Coadministered With BGB-11417

    Time frame: Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose

  5. Parts 1 And 2: AUC From Time Zero To Time t (AUC0-t) Of Azacitidine When Coadministered With BGB-11417

    Time frame: Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose

  6. Parts 1 And 2: AUC From Time Zero To Infinity (AUC0-inf) Of Azacitidine When Coadministered With BGB-11417

    Time frame: Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose

  7. Parts 1 And 2: Apparent Total Clearance Of Azacitidine From Plasma (CL/F) When Coadministered With BGB-11417

    Time frame: Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose

  8. Parts 1 And 2: Apparent Volume Of Distribution (Vz/F) Of Azacitidine When Coadministered With BGB-11417

    Time frame: Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose

  9. Parts 1 And 2: Steady-state AUC From Time Zero To Time Of Last Measurable Concentration (AUClast,ss) Of BGB-11417 When Coadministered With Azacitidine

    Time frame: Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose

  10. Parts 1 And 2: Steady-state Cmax (Cmax,ss) Of BGB-11417 When Coadministered With Azacitidine

    Time frame: Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose

  11. Parts 1 And 2: Steady-state Trough Plasma Concentration (Ctrough,ss) Of BGB-11417 When Coadministered With Azacitidine

    Time frame: Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose

  12. Parts 1 And 2: Steady-state Time To Maximum Observed Plasma Concentration (tmax,ss) Of BGB-11417 When Coadministered With Azacitidine

    Time frame: Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose

  13. Part 3: Number Of Participants Experiencing TEAEs

    Time frame: Approximately 24 months

  14. Part 3: Complete Response Rate

    Time frame: Approximately 24 months

    CR will be defined as the percentage of participants whose BOR is CR. BOR will be defined as the best response recorded from the first dose of study drug until data cut or the initiation of new anticancer treatment.

  15. Part 3 AML Cohort: CR With Incomplete Hematologic Recovery (CRi) Rate

    Time frame: Approximately 24 months

    CRi will be defined as the percentage of participants whose BOR is CRi.

  16. Part 3 AML Cohort: Overall Response Rate (ORR)

    Time frame: Approximately 24 months

    The ORR will include participants whose BOR include CR, CRi, PR, and morphologic leukemia-free state.

  17. Part 3 AML Cohort: Duration Of Response (DOR)

    Time frame: Approximately 24 months

    DOR will be defined as the time from the first response to disease progression documented after treatment initiation or death, whichever occurs first. DOR will include CR, CR plus CRi, overall response (OR), and CR plus CRh.

  18. Part 3 AML Cohort: Time To Response (TTR)

    Time frame: Approximately 24 months

    TTR will be defined as the time from treatment initiation to the first documented response and will include CR, CR plus CRi, OR, and CR plus CRh.

  19. Part 3 Event-free Survival (EFS)

    Time frame: Approximately 24 months

    EFS will be defined as the time from treatment initiation to disease progression, treatment failure, relapse (hematologic relapse for AML) for those who have treatment success, or death due to any cause, whichever happens first.

  20. Part 3 Overall Survival (OS)

    Time frame: Approximately 24 months

    OS will be defined as the time from treatment initiation to death. OS will be analyzed using the same methods as the EFS analysis except for the censoring rules.

  21. Part 3 AML Cohort: Number of Participants with Transfusion Independence

    Time frame: Approximately 24 months

    Transfusion independence will be defined as the proportion of participants whose BOR is transfusion independence. Transfusion independence will need to last for at least 56 consecutive days postbaseline.

  22. Part 3 MDS Cohort: Number Of Participants With Hematological Improvement-erythroid (HI-E)

    Time frame: Approximately 24 months

    The proportion of participants whose BOR is HI-E

  23. Part 3 MDS Cohort: Proportion Of Participants With Hematological Improvement-platelet (HI-P)

    Time frame: Approximately 24 months

    The proportion of participants whose BOR is HI-P

  24. Part 3 MDS Cohort: Proportion Of Participants With Hematological Improvement-neutrophil (HI-N)

    Time frame: Approximately 24 months

    The proportion of participants whose BOR is HI-N will be reported.

  25. Part 3 MDS Cohort: Number of participants with Transfusion Independence

    Time frame: Approximately 24 months

    Transfusion independence will be defined as the percentage of participants whose BOR is transfusion independence. Transfusion independence will need to last for at least 56 consecutive days postbaseline.

  26. Part 3: Ctrough,ss Of BGB-11417 When Coadministered With Azacitidine

    Time frame: Cycle 1 Day 1 and Cycle 2 Day 5 (predose and 4 and 6 hours postdose)

  27. Part 3 MDS cohort: Partial Hematologic Recovery CRh

    Time frame: Approximately 24 months

    Percentage of participants with partial hematologic recovery will be reported

  28. Part 3 AML (Treated with Monotherapy): Complete Response + Morphologic complete Remission with Partial Hematologic Recovery

    Time frame: Approximately 24 months

    Percentage of participants with Complete Response + Morphologic complete Remission with Partial Hematologic Recovery will be reported.

  29. Part 3 AML (Treated with Monotherapy): Steady State trough plasma concentration of BGB-11417

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

  30. Part 3 MDS (Treated with Monotherapy): Modified Overall Response

    Time frame: Approximately 24 months

    Percentage of participants with modified overall response including CR, marrow CR (mCR) or partial remission (PR)

  31. Part 3 MDS (Treated with Monotherapy): Steady State trough plasma concentration of BGB-11417

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

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

1.877.828.5568

Sponsors and collaborators

Lead sponsor

BeOne Medicines

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Feb 25, 2021
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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