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

A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BG-75202, Alone and in Combination With Other Agents, in Patients With Myeloid Malignancies

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 Overview

• Status: Not yet recruiting
• Conditions: Myeloid Malignancy
• Intervention / Treatment: Drug: BG-75202; Drug: Hypomethylation Agent (HMA)

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 877-828-5568; Email: clinicaltrials@beonemed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1a: Part A: Dose escalation, BG-75202 monotherapy; Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.	Drug: BG-75202; Administered orally
Experimental: Phase 1a: Part B: Dose escalation, BG-75202 + Hypomethylation Agent (HMA); Sequential cohorts of increasing dose levels of BG-75202 in combination with Hypomethylation Agent (HMA) will be evaluated.	Drug: BG-75202; Administered orally; Drug: Hypomethylation Agent (HMA); Administered Intravenous (IV) or Subcutaneous (SC)
Experimental: Phase 1b: Dose optimization, BG-75202 monotherapy; Participants will receive BG-75202 monotherapy	Drug: BG-75202; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	Up to approximately 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	Up to approximately 12 months
Phase 1a and Phase 1b: Observed Plasma Maximum Concentration (Cmax) of BG-75202		Up to approximately 5 months
Phase 1a and Phase 1b: Minimum Observed Plasma Concentration (Ctrough) of BG-75202		Up to approximately 5 months
Phase 1a and Phase 1b: Area Under the Plasma Concentration-Time Curve (AUC) of BG-75202		Up to approximately 5 months
Phase 1a and Phase 1b: Terminal Half Life (t1/2) of BG-75202		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.	Up to approximately 18 months

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: KAT6 inhibitor
• Other Study ID Numbers: BG-75202-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No