A Study of BH-30236
Phase 1
170
about 3 years
18+
13 sites in CA, FL, IL +6
What this study is about
Researchers are testing a new medication called BH-30236 in people with relapsed or refractory acute myelogenous leukemia (AML) or higher-risk myelodysplastic syndrome (MDS). The trial will evaluate the safety and how well the medication works, as well as its effects on the body.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take BH-30236
- 2.Take Venetoclax
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
venetoclax
oral
Primary: Dose Escalation and Expansion: Safety evaluation of BH-30236: Number of participants with treatment-related adverse events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Dose Expansion: Composite Complete Remission (CR) Rate
Secondary: Dose Escalation and Expansion: Complete remission (CR) / complete remission with partial hematologic recovery (CRh) rate for AML and complete remission/partial remission (CR/PR) rate for HR-MDS, Dose Escalation and Expansion: Duration of Response (DoR), Dose Escalation and Expansion: Maximum observed blood concentration (Cmax) of BH-30236., Dose Escalation and Expansion: Objective Response Rate (ORR), Dose Escalation and Expansion: Relapse-free Survival (RFS), Dose Escalation: Area under the blood concentration time curve (AUC) of BH-30236.
Oncology