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AzTrials

Acute Myeloid LeukemiaPhase 1/2NCT04771130

A Study of BGB-11417 in Participants With Myeloid Malignancies

A Phase 1/2 study testing BGB-11417, Azacitidine and Posaconazole in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by BeOne Medicines at 47 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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) . Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BGB-11417, Azacitidine and Posaconazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
47 sitesin 10 countries
Study dates
24 May 2021to 31 Aug 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

47 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Study Director contact

1.877.828.5568

clinicaltrials@beonemed.com

47 sites in 10 countries

China12 sites, 10 recruiting

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 100044

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Recruiting

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080

    Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Recruiting

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

    Recruiting

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

    Recruiting

  • The Second Peoples Hospital of Shenzhen

    Shenzhen, Guangdong, 518037

    Completed

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

    Completed

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Recruiting

Other trials in China

Australia11 sites, 11 recruiting

  • Monash Health

    Clayton, Victoria, VIC 3168

    Recruiting

  • Concord Repatriation General Hospital

    Concord, New South Wales, NSW 2139

    Recruiting

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, VIC 3065

    Recruiting

  • Austin Health

    Heidelberg, Victoria, VIC 3084

    Recruiting

  • St George Hospital

    Kogarah, New South Wales, NSW 2217

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, VIC 3004

    Recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia, WA 6150

    Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia, WA 6009

    Recruiting

  • One Clinical Research

    Nedlands, Western Australia, WA 6009

    Recruiting

  • Orange Health Hospital

    Orange, New South Wales, NSW 2800

    Recruiting

  • Gold Coast University Hospital

    Southport, Queensland, QLD 4215

    Recruiting

Other trials in Australia

United States5 sites, 4 recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010-3012

    Terminated

  • Md Anderson Cancer Center

    Houston, Texas, 77030-3907

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226-3522

    Recruiting

  • Upmc Hillman Cancer Center(Univ of Pittsburgh)

    Pittsburgh, Pennsylvania, 15232-1309

    Recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606-3571

    Recruiting

Other trials in United States

Spain4 sites, 4 recruiting

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041

    Recruiting

  • Hospital Universitario de Salamanca

    Salamanca, 37007

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

    Recruiting

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026

    Recruiting

Other trials in Spain

France3 sites, 3 recruiting

  • Hopital Claude Huriez Chu Lille

    Lille, 59000

    Recruiting

  • Hopital Larchet

    Nice, 06200

    Recruiting

  • Hopital Saint Louis

    Paris, 75010

    Recruiting

Other trials in France

Italy3 sites, 3 recruiting

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138

    Recruiting

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

    Meldola, 47014

    Recruiting

  • Niguarda Cancer Center Division of Hematology

    Milan, 20162

    Recruiting

Other trials in Italy

New Zealand3 sites, 3 recruiting

  • North Shore Hospital

    Auckland, 0622

    Recruiting

  • Aotearoa Clinical Trials

    Auckland, 2025

    Recruiting

  • Wellington Regional Hospital (Ccdhb)

    Wellington, 6021

    Recruiting

Other trials in New Zealand

Germany2 sites, 2 recruiting

  • Universitaetsklinikum Leipzig Aor

    Leipzig, 04103

    Recruiting

  • Universitaetsklinikum Ulm

    Ulm, 89081

    Recruiting

Other trials in Germany

South Korea2 sites, 2 recruiting

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351

    Recruiting

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722

    Recruiting

Other trials in South Korea

United Kingdom2 sites

  • Edinburgh Cancer Centre

    Edinburgh, EH4 2XU

    Active, not recruiting

  • The Christie Hospital

    Greater Manchester, M20 4BX

    Active, not recruiting

Other trials in United Kingdom

About this study

Official title: A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients 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) .

Read the detailed description

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.

Being tested
BGB-11417, Azacitidine, Posaconazole
Keywords
BGB-11417, Azacitidine, Posaconazole, AML, MDS, MDS/MPN
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BGB-11417Drug

    Also called Sonrotoclax

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

  • AzacitidineDrug

    Intravenous or subcutaneous administration for 7 days.

  • PosaconazoleDrug

    Oral administration for 8 days on second cycle only.

  • BGB-11417Drug

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

  • BGB-11417Drug

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

Study groups in NCT04771130
Study groupRoleWhat they receive
Parts 1 and 2: AML CohortsExperimentalParticipants with AML will receive BGB-11417 and azacitidine on a 28-day cycle.
Receives: Drug: BGB-11417; Drug: Azacitidine
Parts 1 and 2: MDS CohortsExperimentalParticipants with MDS will receive BGB-11417 and azacitidine on a 28-day cycle.
Receives: Drug: Azacitidine; Drug: BGB-11417
Part 3: AML and MDS CohortsExperimentalParticipants 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.
Receives: Drug: BGB-11417; Drug: Azacitidine; Drug: Posaconazole
Part 3: AML and MDS CohortExperimentalParticipants with MDS and R/R AML (China only) will receive BGB-11417 on a 28-day cycle.
Receives: Drug: BGB-11417

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)

    Measured: 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)

    Measured: Approximately 24 months

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

    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.

    Measured: Approximately 24 months

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

    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).

    Measured: Approximately 24 months

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Cycle 2

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

    Measured: Approximately 24 months

Secondary outcomes (31)

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

    Measured: Approximately 24 months

  2. Parts 1 And 2 MDS Cohort: mOR Rate

    Measured: Approximately 24 months

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Approximately 24 months

  14. Part 3: Complete Response Rate

    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.

    Measured: Approximately 24 months

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

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

    Measured: Approximately 24 months

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

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

    Measured: Approximately 24 months

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

    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.

    Measured: Approximately 24 months

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

    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.

    Measured: Approximately 24 months

  19. Part 3 Event-free Survival (EFS)

    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.

    Measured: Approximately 24 months

  20. Part 3 Overall Survival (OS)

    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.

    Measured: Approximately 24 months

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

    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.

    Measured: Approximately 24 months

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

    The proportion of participants whose BOR is HI-E

    Measured: Approximately 24 months

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

    The proportion of participants whose BOR is HI-P

    Measured: Approximately 24 months

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

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

    Measured: Approximately 24 months

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

    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.

    Measured: Approximately 24 months

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

    Measured: 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

    Percentage of participants with partial hematologic recovery will be reported

    Measured: Approximately 24 months

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

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

    Measured: Approximately 24 months

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

    Measured: 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

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

    Measured: Approximately 24 months

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2021
  2. Study start24 May 2021
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04771130
Sponsor's protocol ID
BGB-11417-103
Other IDs
2021-003285-12, 2023-508881-14-00, CTR20213416, 2023
Status last verified
Sep 2026
First submitted
23 Feb 2021
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BGB-11417, Azacitidine and Posaconazole in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by BeOne Medicines at 47 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in China, Australia, United States, Spain, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (1.877.828.5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04771130.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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