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

NCT07619287 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BG-75202-102
• Study Type: interventional
• Target: 118
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Myeloid Malignancy

Keywords

KAT6 inhibitor

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

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

  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)

  Up to approximately 12 months

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

  Up to approximately 12 months

• Phase 1a: Dose Escalation: CR + CRh Rate

  Up to approximately 12 months

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

  Up to approximately 12 months

Study Arms (3)

Phase 1a: Part A: Dose escalation, BG-75202 monotherapy

EXPERIMENTAL

Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy.

Drug: BG-75202

Phase 1a: Part B: Dose escalation, BG-75202 + Hypomethylation Agent (HMA)

EXPERIMENTAL

Sequential cohorts of increasing dose levels of BG-75202 in combination with Hypomethylation Agent (HMA) will be evaluated.

Drug: BG-75202; Drug: Hypomethylation Agent (HMA)

Phase 1b: Dose optimization, BG-75202 monotherapy

EXPERIMENTAL

Participants will receive BG-75202 monotherapy

Drug: BG-75202

Interventions

BG-75202 DRUG

Administered orally

Phase 1a: Part A: Dose escalation, BG-75202 monotherapy; Phase 1a: Part B: Dose escalation, BG-75202 + Hypomethylation Agent (HMA); Phase 1b: Dose optimization, BG-75202 monotherapy

Hypomethylation Agent (HMA) DRUG

Administered Intravenous (IV) or Subcutaneous (SC)

Phase 1a: Part B: Dose escalation, BG-75202 + Hypomethylation Agent (HMA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (4)

Icon Cancer Centre Kurralta Park

Kurralta Park, South Australia, SA 5037, Australia

RECRUITING

Linear Clinical Research

Nedlands, Western Australia, WA 6009, Australia

RECRUITING

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

Tianjin, Tianjin Municipality, 301617, China

RECRUITING

Auckland City Hospital

Auckland, 1023, New Zealand

RECRUITING

Study Officials

• Study Director

  BeOne Medicine

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

877-828-5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 1, 2026
• Study Start: June 23, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

NZ (1); AU (2); CN (1)