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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a: Part A: Dose escalation, BG-75202 monotherapy | Experimental | Sequential cohorts of increasing dose levels of BG-75202 will be evaluated as monotherapy. |
|
| 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. |
|
| Phase 1b: Dose optimization, BG-75202 monotherapy | Experimental | Participants will receive BG-75202 monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG-75202 | Drug | Administered orally |
|
| 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,
| 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 |
| 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 |
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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:
Patients must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 877-828-5568 | clinicaltrials@beonemed.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeOne Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icon Cancer Centre Kurralta Park | Recruiting | Kurralta Park | South Australia | SA 5037 | Australia | |
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See plan description
See plan description
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| Hypomethylation Agent (HMA) | Drug | Administered Intravenous (IV) or Subcutaneous (SC) |
|
| 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 |
| Linear Clinical Research |
| Recruiting |
| Nedlands |
| Western Australia |
| WA 6009 |
| Australia |
| Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch | Recruiting | Tianjin | Tianjin Municipality | 301617 | China |
| Auckland City Hospital | Recruiting | Auckland | 1023 | New Zealand |