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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
Administered orally
Administered Intravenous (IV) or Subcutaneous (SC)
Concord Repatriation General Hospital
Concord, New South Wales, Australia
RECRUITINGPart 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
Time frame: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately18 months
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.
Time frame: Estimated approximately 18 months
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.
Time frame: Up to approximately 12 months
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.
Time frame: Up to approximately 12 months
Phase 1b Dose Optimization: Number of Participants with Adverse Events (AEs)
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St George Hospital
Kogarah, New South Wales, Australia
RECRUITINGIcon Cancer Centre Kurralta Park
Kurralta Park, South Australia, Australia
RECRUITINGAustin Health
Heidelberg, Victoria, Australia
RECRUITINGLinear Clinical Research
Nedlands, Western Australia, Australia
RECRUITINGThe First Hospital of Lanzhou University
Lanzhou, Gansu, China
RECRUITINGZhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGThe Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou Universitysouth Branch
Zhengzhou, Henan, China
RECRUITINGTongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITING...and 6 more locations
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.
Time frame: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 18 months
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.
Time frame: Up to approximately 12 months
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.
Time frame: Up to approximately 12 months
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.
Time frame: Up to approximately 12 months
Phase 1a and Phase 1b: Overall response rate (ORR)
ORR is defined as the percentage of participants who achieved a best response of CR, CRh, CRi, or partial response (PR) as assessed by investigator's review.
Time frame: Up to approximately 12 months
Phase 1b: Event Free Survival (EFS)
EFS, defined as the time from the randomization date for Phase 1b, to the date of first documentation of treatment failure per European LeukemiaNet (ELN) 2022 (refractory disease and relapsed disease) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 18 months
Phase 1b: Overall Survival (OS)
OS, defined as the time from the randomization date for Phase to the date of death due to any cause.
Time frame: Up to approximately 18 months
Phase 1b: Transfusion Independence
Transfusion independence, defined as the proportion of patients who achieve red blood cell and/or platelet transfusion independence according to protocol specified criteria, among patients who are transfusion-dependent at baseline.
Time frame: Up to approximately 12 months
Phase 1a and Phase 1b: Observed Plasma Maximum Concentration (Cmax) of BG-75202
Time frame: Up to approximately 5 months
Phase 1a and Phase 1b: Minimum Observed Plasma Concentration (Ctrough) of BG-75202
Time frame: Up to approximately 5 months
Phase 1a and Phase 1b: Area Under the Plasma Concentration-Time Curve (AUC) of BG-75202
Time frame: Up to approximately 5 months
Phase 1a and Phase 1b: Terminal Half Life (t1/2) of BG-75202
Time frame: Up to approximately 5 months
Phase 1b: Recommended Phase 2 Dose (RP2D)
The RP2D of BG-75202 takes into consideration the totality of data including, but not limited to, PK, pharmacodynamics, safety, tolerability, and antitumor activity.
Time frame: Up to approximately 18 months