A Study of BGB-11417 in Participants With Myeloid Malignancies

BeiGene

Status and phase: Enrolling; Phase 2; Phase 1

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04771130

BGB-11417-103

2021-003285-12 (EudraCT 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) .

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. Prior malignancy within the past 2 years, except for curatively treated 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 or azacitidine except for participants who meet HMA-failure criteria
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: BGB-11417

Drug: BGB-11417

Drug: BGB-11417

Drug: Azacitidine

Drug: Posaconazole

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