NCT06285890

Phase I Study of HC-7366 for Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To find a recommended dose of HC-7366 to patients with AML. The safety and effects of this drug combination will also be studied.

Detailed description

Primary Objective: \- To evaluate safety of HC-7366 Secondary Objectives: * To estimate rate of CR/CRh/CRi by 4 cycles * To estimate overall response rate (ORR) * To estimate rate of MRD negative by 4 cycles * To estimate overall survival (OS) * To estimate relapse-free survival (RFS) Exploratory Objectives * To determine the plasma concentration and pharmacokinetic (PK) parameters of HC-7366 when dosed in combination with azole antifungals in AML patients. * To estimate duration of response (DOR) * To estimate median time to blood count recovery * To estimate median time to first response * To estimate median time to negative MRD * To study drug-drug interactions with CYP3A4 inhibitor azole antifungals * Additional response and survival endpoints. * To explore biomarkers of response, pathway engagement, and resistance

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	HC-7366	Given by PO

Timeline

• Start date: 2024-05-20
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2024-02-29
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study