Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BH-30236 · 1 trial · 6 indications
DLTs are dose-limiting toxicities as defined in the study protocol.
Frequency, severity and relationship to study drug of AEs and SAEs
Composite CR rate disease assessment in accordance with the following guidelines: European Leukemia Network (ELN) 2022 for acute myelogenous leukemia (AML) and International Working Group (IWG) 2023 for myelodysplastic syndrome (MDS).
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Cohort - Monotherapy | EXPERIMENTAL | BH-30236 Monotherapy for Dose Escalation |
| Dose Escalation Cohort - Combination with Venetoclax | EXPERIMENTAL | BH-30236 in Combination with Venetoclax for Dose Escalation. |
| Dose Expansion Cohort - Monotherapy | EXPERIMENTAL | BH-30236 based on Monotherapy dose escalation data. |
| Dose Expansion Cohort - Combination with Venetoclax | EXPERIMENTAL | BH-30236 in Combination with Venetoclax based on Dose Escalation data |
| Name | Type | Description |
|---|---|---|
| BH-30236 | DRUG | BH-30236 will be provided as either a 5 mg, 15 mg or 30 mg tablet. Participants will take BH-30236 tablets orally depending on their dose level assignment. |
| Venetoclax | DRUG | Venetoclax will be provided as 10 mg, 50 mg or 100 mg tablets. Participants will take venetoclax orally per label instructions. |
Inclusion criteria: * ≥18 years. * Diagnosis of relapsed/refractory acute myelogenous leukemia (R/R) AML or higher-risk myelodysplastic syndrome (HR-MDS) with ≥5% bone marrow blast at time of inclusion. * Prior treatment history must include 1-5 prior lines of therapy. * ECOG performance status ≤2....
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