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Myeloid MalignancyPhase 1NCT07619287

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

A Phase 1 study testing BG-75202 and Hypomethylation Agent (HMA) in people with Myeloid Malignancy, run by BeOne Medicines at 17 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloid Malignancy
What is being tested?
BG-75202 and Hypomethylation Agent (HMA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
17 sitesin 3 countries
Study dates
23 Jun 2026to 30 Sep 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

17 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Study Director contact

877-828-5568

clinicaltrials@beonemed.com

17 sites in 3 countries

China9 sites, 9 recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

    Recruiting

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

    Recruiting

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

    Recruiting

  • The First Affiliated Hospital of Nanchang University Branch Xianghu

    Nanchang, Jiangxi, 332000

    Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Recruiting

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch

    Tianjin, Tianjin Municipality, 301617

    Recruiting

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Recruiting

  • The First Affiliated Hospital of Zhengzhou Universitysouth Branch

    Zhengzhou, Henan, 451161

    Recruiting

Other trials in China

Australia6 sites, 6 recruiting

  • Concord Repatriation General Hospital

    Concord, New South Wales, NSW 2139

    Recruiting

  • Barwon Health the Geelong Hospital

    Geelong, Victoria, VIC 3220

    Recruiting

  • Austin Health

    Heidelberg, Victoria, VIC 3084

    Recruiting

  • St George Hospital

    Kogarah, New South Wales, NSW 2217

    Recruiting

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, South Australia, SA 5037

    Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia, WA 6009

    Recruiting

Other trials in Australia

New Zealand2 sites, 2 recruiting

  • North Shore Hospital

    Auckland, 0622

    Recruiting

  • Auckland City Hospital

    Auckland, 1023

    Recruiting

Other trials in New Zealand

About this study

Official 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

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.

Being tested
BG-75202, Hypomethylation Agent (HMA)
Keywords
KAT6 inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BG-75202Drug

    Administered orally

  • Hypomethylation Agent (HMA)Drug

    Administered Intravenous (IV) or Subcutaneous (SC)

Study groups in NCT07619287
Study groupRoleWhat they receive
Phase 1a: Part A: Dose escalation, BG-75202 monotherapyExperimentalSequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.
Receives: Drug: BG-75202
Phase 1a: Part B: Dose escalation, BG-75202 + Hypomethylation Agent (HMA)ExperimentalSequential cohorts of increasing dose levels of BG-75202 in combination with Hypomethylation Agent (HMA) will be evaluated.
Receives: Drug: BG-75202; Drug: Hypomethylation Agent (HMA)
Phase 1b: Dose optimization, BG-75202 monotherapyExperimentalParticipants will receive BG-75202 monotherapy
Receives: Drug: BG-75202

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately18 months

  2. 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.

    Measured: Estimated approximately 18 months

  3. 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.

    Measured: Up to approximately 12 months

  4. 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.

    Measured: Up to approximately 12 months

Secondary outcomes (13)

  1. 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.

    Measured: From first dose to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 18 months

  2. 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.

    Measured: Up to approximately 12 months

  3. 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.

    Measured: Up to approximately 12 months

  4. 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.

    Measured: Up to approximately 12 months

  5. 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.

    Measured: Up to approximately 12 months

  6. 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.

    Measured: Up to approximately 18 months

  7. 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.

    Measured: Up to approximately 18 months

  8. 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.

    Measured: Up to approximately 12 months

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

    Measured: Up to approximately 5 months

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

    Measured: Up to approximately 5 months

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

    Measured: Up to approximately 5 months

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

    Measured: Up to approximately 5 months

  13. 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.

    Measured: Up to approximately 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2026
  2. Study start23 Jun 2026
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07619287
Sponsor's protocol ID
BG-75202-102
Status last verified
Jun 2026
First submitted
22 May 2026
Last updated
28 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BG-75202 and Hypomethylation Agent (HMA) in people with Myeloid Malignancy, run by BeOne Medicines at 17 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (877-828-5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07619287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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