An Investigational Study of BG-75202 Alone and in Combination With Other Agents in Patients With Myeloid Malignancies

BeOne Medicines

Status and phase: Not yet enrolling; Phase 1

Conditions: Myeloid Malignancy

Treatments: Drug: BG-75202; Drug: Hypomethylation Agent (HMA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07619287

BG-75202-102

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of BG-75202 (KAT6A/B inhibitor) alone and in combination with other agents in patients with myeloid malignancies.

Enrollment: 118 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), inclusive, at the time of signing the Informed consent form (ICF).

• Patients must have a confirmed diagnosis of myeloid malignancies based on 2016 World Health Organization criteria, and meet the following categories:

  • Relapsed/refractory; myeloid malignancies after ≥1 prior systemic therapy, per ELN; 2022 criteria; patients with actionable genetic alteration must have previously received targeted therapies unless contraindicated, unavailable/inaccessible, or declined by patient.

• Patients must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

Exclusion criteria

• Prior exposure to KAT6A/B inhibitors/degraders.
• A diagnosis of acute promyelocytic leukemia or BCR-ABL-positive leukemia.
• Known central nervous system involvement by leukemia
• Use of antileukemic therapies without sufficient washout period

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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118 participants in 3 patient groups

Phase 1a: Part A: Dose escalation, BG-75202 monotherapy

Experimental group

Description:

Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.

Treatment:

Drug: BG-75202

Phase 1a: Part B: Dose escalation, BG-75202 + Hypomethylation Agent (HMA)

Experimental group

Description:

Sequential cohorts of increasing dose levels of BG-75202 in combination with Hypomethylation Agent (HMA) will be evaluated.

Treatment:

Drug: Hypomethylation Agent (HMA)

Drug: BG-75202

Phase 1b: Dose optimization, BG-75202 monotherapy

Experimental group

Description:

Participants will receive BG-75202 monotherapy

Treatment:

Drug: BG-75202