Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07619287 | An Investigational Study of BG-75202 Alone and in Combination With Other Agents in Patients With Myeloid Malignancies | PHASE1 | NOT YET_RECRUITING | 118 | — | — | Jun 1, 2026 | Sep 30, 2028 | Jun 1, 2026 | - | — |
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
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.
CR rate is defined as the percentage of participants who achieved a best response of CR as assessed by investigator's review.
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| BG-75202 | DRUG | Administered orally |
| Hypomethylation Agent (HMA) | DRUG | Administered Intravenous (IV) or Subcutaneous (SC) |
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 He...