Clinical Trials in China / NCT07619287
Recruiting
Phase 1
An Investigational Study of BG-75202 Alone and in Combination With Other Agents in Patients With Myeloid Malignancies
NCT07619287 · tracked via the Priya Life Science China tracker
Condition(s) studied
Myeloid Malignancy
Investigational drug(s) / intervention(s)
BG-75202 →Hypomethylation Agent (HMA)
BG-75202: Administered orally
Hypomethylation Agent (HMA): Administered Intravenous (IV) or Subcutaneous (SC)
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Part 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — 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 - Phase 1a: Recommended Dose for Expansion (RDFE) of BG-75202 — 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. - Phase 1b: Dose Optimization: Complete Remission (CR) Rate — 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. - Phase 1b: Dose Optimization: Complete Remission (CR) plus CR With Partial Hematologic Recovery (CRh) Rate — 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.
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| Concord Repatriation General Hospital | Concord | New South Wales | Recruiting |
| St George Hospital | Kogarah | New South Wales | Recruiting |
| Icon Cancer Centre Kurralta Park | Kurralta Park | South Australia | Recruiting |
| Barwon Health the Geelong Hospital | Geelong | Victoria | Recruiting |
| Austin Health | Heidelberg | Victoria | Recruiting |
| Linear Clinical Research | Nedlands | Western Australia | Recruiting |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | Recruiting |
| Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong | Recruiting |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | Recruiting |
| The First Affiliated Hospital of Zhengzhou Universitysouth Branch | Zhengzhou | Henan | Recruiting |
| Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | Recruiting |
| The First Affiliated Hospital of Nanchang University Branch Donghu | Nanchang | Jiangxi | Recruiting |
| The First Affiliated Hospital of Nanchang University Branch Xianghu | Nanchang | Jiangxi | Recruiting |
| Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch | Tianjin | Tianjin Municipality | Recruiting |
| North Shore Hospital | Auckland | New Zealand | Recruiting |
| Auckland City Hospital | Auckland | New Zealand | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07619287 on ClinicalTrials.gov ↗ ← All trials in China