OncoMatch/Clinical Trials/NCT06285890
Phase I Study of HC-7366 for Acute Myeloid Leukemia
Is NCT06285890 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies HC-7366 for acute myeloid leukemia.
Treatment: HC-7366 — To find a recommended dose of HC-7366 to patients with AML. The safety and effects of this drug combination will also be studied.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Allowed: TP53 mutation
Participants relapsing with persistent or new TP53 mutation will be eligible irrespective of CR1 duration.
Allowed: FLT3 actionable mutation
Patients with actionable mutations with available FDA-approved therapies, e.g., FLT3, IDH1/2 inhibitors may be enrolled after they have exhausted appropriate lines of FDA approved treatment options.
Allowed: IDH1 actionable mutation
Patients with actionable mutations with available FDA-approved therapies, e.g., FLT3, IDH1/2 inhibitors may be enrolled after they have exhausted appropriate lines of FDA approved treatment options.
Allowed: IDH2 actionable mutation
Patients with actionable mutations with available FDA-approved therapies, e.g., FLT3, IDH1/2 inhibitors may be enrolled after they have exhausted appropriate lines of FDA approved treatment options.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: intensive induction chemotherapy (purine analogue containing intensive induction chemotherapy regimen (e.g., FLAG-Ida, CLIA or CLAG-M or similar regimens with or without venetoclax), intensive induction chemotherapy with venetoclax (e.g., 7 + 3 or CPX-251 with venetoclax or similar regimens), intensive induction chemotherapy such as 7 + 3 or 5 + 2 or similar regimens without venetoclax, venetoclax with HMA/LDAC +/- other agents, HMA alone) — relapsed or refractory
Appropriate prior therapy in order for patient to be deemed relapsed or refractory include any of the following: i. At least 1 cycle of purine analogue containing intensive induction chemotherapy regimen, e.g., FLAG-Ida, CLIA or CLAG-M or similar regimens with or without venetoclax. ii. At least 1 cycle of intensive induction chemotherapy with venetoclax, e.g., 7 + 3 or CPX-251 with venetoclax or similar regimens iii. At least 2 cycles of intensive induction chemotherapy such as 7 + 3 or 5 + 2 or similar regimens without venetoclax iv. 2 cycles of venetoclax with HMA/LDAC +/- other agents v. 4 cycles of HMA alone
Cannot have received: cytotoxic chemotherapy, targeted therapy, radiation therapy, immunotherapy, or other clinical trial therapies
Exception: hydroxyurea or cytarabine for control of WBC count during washout period is permitted
Prior use of any cytotoxic chemotherapy, targeted therapy, radiation therapy, immunotherapy, or other clinical trial therapies within 2 weeks, prior to first dose of study treatment. Patients may receive hydroxyurea or cytarabine for control of WBC count during this washout period.
Lab requirements
Kidney function
creatinine clearance ≥ 45 mL/min calculated by the Cockcroft-Gault formula or MDRD equation or measured by 24-hour urine collection
Liver function
total bilirubin ≤1.5 x ULN unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT ≤ 2.5 x ULN unless considered due to leukemic involvement, in which case total bilirubin or AST and/or ALT ≤ 3 x ULN will be considered eligible
Adequate hepatic function (total bilirubin ≤1.5 x upper limit of normal (ULN) unless increase is due to Gilberts's disease or leukemic involvement, and AST and/or ALT ≤ 2.5 x ULN unless considered due to leukemic involvement, in which case total bilirubin or AST and/or ALT ≤ 3 x ULN will be considered eligible). Adequate renal function with creatinine clearance ≥ 45 mL/min calculated by the Cockcroft-Gault formula or MDRD equation or measured by 24-hour urine collection.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06285890 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cytotoxic chemotherapy, targeted therapy, radiation therapy, immunotherapy, or other clinical trial therapies disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages