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.
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).
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.
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
Sequential
BG-75202
DrugAdministered orally
Hypomethylation Agent (HMA)
DrugAdministered Intravenous (IV) or Subcutaneous (SC)
Part 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporarily associated with the use of study treatment, whether considered related to study treatment or not. An SAE is any untoward medical occurrence that, at any dose, * Results in death * Is life-threatening * Requires hospitalization or prolongation of existing hospitalization * Results in disability/incapacity * Is congenital anomaly/birth defect * Is considered a significant medical AE by the investigator based on medical judgement
Phase 1a: Recommended Dose for Expansion (RDFE) of BG-75202
The potential RDFE(s) of BG-75202 as monotherapy or in combination with HMA are based upon the maximum tolerated dose (MTD) or maximum administered dose (MAD), with consideration of the tolerability, pharmacokinetics (PK), pharmacodynamics, antitumor activity, and any other available relevant data.
Phase 1b: Dose Optimization: Complete Remission (CR) Rate
CR rate is defined as the percentage of participants who achieved a best response of CR as assessed by investigator's review.
Phase 1b: Dose Optimization: Complete Remission (CR) plus CR With Partial Hematologic Recovery (CRh) Rate
CR + CRh rate is defined as the percentage of participants who achieved the best response of CR or CRh as assessed by investigator's review.
Phase 1b Dose Optimization: Number of Participants with Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporarily associated with the use of study treatment, whether considered related to study treatment or not.
Phase 1b: Time to Response (TTR)
TTR for CR, CR + CRi, CR + CRh, and ORR, defined as the time from the randomization date, to the first determination of the respective objective response.
Phase 1b: CR + Complete Remission with Incomplete Hematologic Recovery (CRi) Rate
CR + CRi rate is defined as the percentage of patients who achieved a best response of CR or CRi as assessed by investigator's review.
Phase 1a: Dose Escalation: CR + CRh Rate
CR + CRh rate is defined as the percentage of patients who achieved a best response of CR or CRh as assessed by investigator's review.
Click on the lead sponsor to view all of their trials.
