Ignite Creation Date:
2024-07-17 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501196
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-17
Brief Title:
A Study of BH-30236 in Relapsed Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
Sponsor:
BlossomHill Therapeutics
Organization:
BlossomHill Therapeutics
Study Overview
Official Title:
A Phase 11b Open-Label Dose Escalation First-in- Human Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Anti-leukemic Activity of the Orally Available CDC-Like Kinase CLK Inhibitor BH-30236 in Adults With Relapsed or Refractory Acute Myelogenous Leukemia RR AML or Higher-Risk Myelodysplastic Syndrome HR-MDS
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study BH-30236-01 is a first-in-human FIH Phase 11b open-label dose escalation and expansion study in participants with relapsedrefractory acute myelogenous leukemia RR AML or higher-risk myelodysplastic syndrome HR-MDS
Phase 1 Dose Escalation will evaluate the safety tolerability pharmacokinetics PK pharmacodynamics PD and preliminary efficacy of BH-30236 administered orally Approximately 50 participants may be enrolled in Phase 1 of the study
Phase 1b Dose Expansion will follow Phase 1 to further understand the relationships among dose exposure toxicity tolerability and clinical activity Up to 24 participants may be enrolled in Phase 1b of the study
The dose expansion part Phase 1b will be followed to understand the relationships among dose exposure toxicity tolerability and clinical activity Up to 24 participants may be enrolled in Phase 1b of the study
Phase 1 Dose Escalation will evaluate the safety tolerability pharmacokinetics PK pharmacodynamics PD and preliminary efficacy of BH-30236 administered orally Approximately 50 participants may be enrolled in Phase 1 of the study
Phase 1b Dose Expansion will follow Phase 1 to further understand the relationships among dose exposure toxicity tolerability and clinical activity Up to 24 participants may be enrolled in Phase 1b of the study
The dose expansion part Phase 1b will be followed to understand the relationships among dose exposure toxicity tolerability and clinical activity Up to 24 participants may be enrolled in Phase 1b of the study
Detailed Description:
This is a Phase 11b multi-center open-label dose escalation first-in-human study to evaluate the safety tolerability PK PD and preliminary anti-leukemic activity of the CLK inhibitor BH-30236 in adult subjects with RR AML or HR-MDS
The study consists of two parts Phase 1 Dose Escalation and Phase 1b Dose Expansion
Phase 1 Dose Escalation is anticipated to enroll approximately 50 subjects to evaluate the safety tolerability PK PD and preliminary anti-leukemic activity of BH-30236 as well as determine the MTD andor the preliminary recommended doses for expansion RDEs
Phase 1 will follow an accelerated 3 3 dose escalation where participants will receive ascending doses of BH-30236 to determine the recommended RDEs
Phase 1b Dose Expansion will enroll approximately 24 subjects to evaluate the safety tolerability and preliminary anti-leukemic activity of BH-30236 at selected RDEs determined in Phase 1 Dose Escalation
The study consists of two parts Phase 1 Dose Escalation and Phase 1b Dose Expansion
Phase 1 Dose Escalation is anticipated to enroll approximately 50 subjects to evaluate the safety tolerability PK PD and preliminary anti-leukemic activity of BH-30236 as well as determine the MTD andor the preliminary recommended doses for expansion RDEs
Phase 1 will follow an accelerated 3 3 dose escalation where participants will receive ascending doses of BH-30236 to determine the recommended RDEs
Phase 1b Dose Expansion will enroll approximately 24 subjects to evaluate the safety tolerability and preliminary anti-leukemic activity of BH-30236 at selected RDEs determined in Phase 1 Dose Escalation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None