Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07619287

An Investigational Study 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Myeloid Malignancy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Icon Cancer Centre Kurralta Park, Kurralta Park, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BG-75202

Drug

Administered orally

Hypomethylation Agent (HMA)

Drug

Administered Intravenous (IV) or Subcutaneous (SC)

Primary outcomes

  1. Part 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    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

    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

  2. Phase 1a: Recommended Dose for Expansion (RDFE) of BG-75202

    Time frame: Estimated approximately 18 months

    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.

  3. Phase 1b: Dose Optimization: Complete Remission (CR) Rate

    Time frame: Up to approximately 12 months

    CR rate is defined as the percentage of participants who achieved a best response of CR as assessed by investigator's review.

  4. Phase 1b: Dose Optimization: Complete Remission (CR) plus CR With Partial Hematologic Recovery (CRh) Rate

    Time frame: Up to approximately 12 months

    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.

Secondary outcomes

  1. Phase 1b Dose Optimization: Number of Participants with Adverse Events (AEs)

    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

    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.

  2. Phase 1b: Time to Response (TTR)

    Time frame: Up to approximately 12 months

    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.

  3. Phase 1b: CR + Complete Remission with Incomplete Hematologic Recovery (CRi) Rate

    Time frame: Up to approximately 12 months

    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.

  4. Phase 1a: Dose Escalation: CR + CRh Rate

    Time frame: Up to approximately 12 months

    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.

  5. Phase 1a and Phase 1b: Overall response rate (ORR)

    Time frame: Up to approximately 12 months

    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.

  6. Phase 1b: Event Free Survival (EFS)

    Time frame: Up to approximately 18 months

    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.

  7. Phase 1b: Overall Survival (OS)

    Time frame: Up to approximately 18 months

    OS, defined as the time from the randomization date for Phase to the date of death due to any cause.

  8. Phase 1b: Transfusion Independence

    Time frame: Up to approximately 12 months

    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.

  9. Phase 1a and Phase 1b: Observed Plasma Maximum Concentration (Cmax) of BG-75202

    Time frame: Up to approximately 5 months

  10. Phase 1a and Phase 1b: Minimum Observed Plasma Concentration (Ctrough) of BG-75202

    Time frame: Up to approximately 5 months

  11. Phase 1a and Phase 1b: Area Under the Plasma Concentration-Time Curve (AUC) of BG-75202

    Time frame: Up to approximately 5 months

  12. Phase 1a and Phase 1b: Terminal Half Life (t1/2) of BG-75202

    Time frame: Up to approximately 5 months

  13. Phase 1b: Recommended Phase 2 Dose (RP2D)

    Time frame: Up to approximately 18 months

    The RP2D of BG-75202 takes into consideration the totality of data including, but not limited to, PK, pharmacodynamics, safety, tolerability, and antitumor activity.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

877-828-5568

Sponsors and collaborators

Lead sponsor

BeOne Medicines

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 1, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.