A Study of BGB-11417 in Participants With 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
4 other identifiers
interventional
260
10 countries
46
Brief 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) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2021
Longer than P75 for phase_1
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2021
CompletedFirst Posted
Study publicly available on registry
February 25, 2021
CompletedStudy Start
First participant enrolled
May 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 8, 2028
April 23, 2026
April 1, 2026
6.7 years
February 23, 2021
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
Cycle 1 (Up to 28 days for non-hematologic DLTs and up to 42 days for hematologic DLTs)
Part 1 And 2: Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Approximately 24 months
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.
Approximately 24 months
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).
Approximately 24 months
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
Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)
Part 3 AML Cohort (DDI Sub-cohort): Maximum Observed Plasma Concentration (Cmax) Of BGB-11417 When Administered Alone and When Co-administered With Posaconazole
Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)
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
Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, , 4, 6, 8, and 24 hours postdose)
Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number Of Participants Experiencing DLTs
Cycle 2
Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number of Participants Experiencing TEAEs
Approximately 24 months
Secondary Outcomes (31)
Parts 1 And 2 AML Cohort: Complete remission (CR) + Morphologic CR With Partial Hematologic Recovery (CRh)
Approximately 24 months
Parts 1 And 2 MDS Cohort: mOR Rate
Approximately 24 months
Parts 1 And 2: Cmax Of Azacitidine When Coadministered With BGB-11417
Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
Parts 1 And 2: Terminal Half-life (t1/2) Of Azacitidine When Coadministered With BGB-11417
Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
Parts 1 And 2: AUC From Time Zero To Time t (AUC0-t) Of Azacitidine When Coadministered With BGB-11417
Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose
- +26 more secondary outcomes
Study Arms (4)
Parts 1 and 2: AML Cohorts
EXPERIMENTALParticipants with AML will receive BGB-11417 and azacitidine on a 28-day cycle.
Parts 1 and 2: MDS Cohorts
EXPERIMENTALParticipants with MDS will receive BGB-11417 and azacitidine on a 28-day cycle.
Part 3: AML and MDS Cohorts
EXPERIMENTALParticipants 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.
Part 3: AML and MDS Cohort
EXPERIMENTALParticipants with MDS and R/R AML (China only) will receive BGB-11417 on a 28-day cycle.
Interventions
Oral administration for 10, 21, 14 or 28 days on a 28-day cycle.
Intravenous or subcutaneous administration for 7 days.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (46)
City of Hope National Medical Center
Duarte, California, 91010-3012, United States
Tampa General Hospital
Tampa, Florida, 33606-3571, United States
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, 15232-1309, United States
Md Anderson Cancer Center
Houston, Texas, 77030-3907, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-1222, United States
Concord Repatriation General Hospital
Concord, New South Wales, NSW 2139, Australia
St George Hospital
Kogarah, New South Wales, NSW 2217, Australia
Orange Health Hospital
Orange, New South Wales, NSW 2800, Australia
Gold Coast University Hospital
Southport, Queensland, QLD 4215, Australia
Monash Health
Clayton, Victoria, VIC 3168, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, VIC 3065, Australia
Austin Health
Heidelberg, Victoria, VIC 3084, Australia
The Alfred Hospital
Melbourne, Victoria, VIC 3004, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, WA 6150, Australia
Linear Clinical Research
Nedlands, Western Australia, WA 6009, Australia
One Clinical Research
Nedlands, Western Australia, WA 6009, Australia
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 510080, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
The Second Peoples Hospital of Shenzhen
Shenzhen, Guangdong, 518037, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Hopital Claude Huriez Chu Lille
Lille, 59000, France
Hopital Larchet
Nice, 06200, France
Hopital Saint Louis
Paris, 75010, France
Universitaetsklinikum Leipzig Aor
Leipzig, 04103, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, 40138, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, 47014, Italy
Niguarda Cancer Center Division of Hematology
Milan, 20162, Italy
North Shore Hospital
Auckland, 0622, New Zealand
Wellington Regional Hospital (Ccdhb)
Wellington, 6021, New Zealand
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitari I Politecnic La Fe
Valencia, 46026, Spain
Edinburgh Cancer Centre
Edinburgh, EH4 2XU, United Kingdom
The Christie Hospital
Greater Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2021
First Posted
February 25, 2021
Study Start
May 24, 2021
Primary Completion (Estimated)
February 8, 2028
Study Completion (Estimated)
February 8, 2028
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeiGene 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. BeiGene 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 BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.