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NCT07619287
An Investigational Study of BG-75202 Alone and in Combination With Other Agents in Patients With Myeloid Malignancies
Conditions: Myeloid Malignancy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 118
Sponsor: BeOne Medicines
Location: Concord Repatriation General Hospital Concord New South Wales
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07619287). StuddyBuddy aggregates publicly available trial information.