A Study of BGB-11417 in Participants With Myeloid Malignancies

BeOne Medicines

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasm; Acute Myeloid Leukemia

Treatments: Drug: BGB-11417; Drug: Azacitidine; Drug: Posaconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT04771130

BGB-11417-103

CTR20213416 (Registry Identifier)

2021-003285-12 (EudraCT Number)

2023-508881-14-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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) .

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 4 patient groups

Parts 1 and 2: AML Cohorts

Experimental group

Description:

Participants with AML will receive BGB-11417 and azacitidine on a 28-day cycle.

Treatment:

Drug: BGB-11417

Drug: BGB-11417

Drug: BGB-11417

Drug: Azacitidine

Parts 1 and 2: MDS Cohorts

Experimental group

Description:

Participants with MDS will receive BGB-11417 and azacitidine on a 28-day cycle.

Treatment:

Drug: BGB-11417

Drug: BGB-11417

Drug: BGB-11417

Drug: Azacitidine

Part 3: AML and MDS Cohorts

Experimental group

Description:

Participants 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.

Treatment:

Drug: Posaconazole

Drug: BGB-11417

Drug: BGB-11417

Drug: BGB-11417

Drug: Azacitidine

Part 3: AML and MDS Cohort

Experimental group

Description:

Participants with MDS and R/R AML (China only) will receive BGB-11417 on a 28-day cycle.

Treatment:

Drug: BGB-11417

Drug: BGB-11417

Drug: BGB-11417