Clinical Trials

Multiple Phase I clinical trials sponsored by HiberCell, Inc. and M.D. Anderson Cancer Center are evaluating the safety, tolerability, and preliminary efficacy of the first-in-human GCN2 modulator HC-7366 as monotherapy or combination regimens across various oncological indications. Although a clinical trial in advanced solid tumors—including colorectal, head and neck, non-small cell lung, and bladder carcinomas—was terminated, several clinical trials are currently recruiting participants. These ongoing Phase I trials focus on renal cell carcinoma, kidney cancer, and acute myeloid leukemia.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06285890 RECRUITING
Acute Myeloid Leukemia
M.D. Anderson Cancer Center
 2024-05-20 PHASE1
NCT07401875 RECRUITING
Phase 1b; HC-7366; SHARK; Kidney Cancer
M.D. Anderson Cancer Center
 2026-03-24 PHASE1
NCT06234605 RECRUITING
Renal Cell Carcinoma
HiberCell, Inc.
 2024-04-29 PHASE1
NCT05121948 TERMINATED
Squamous Cell Carcinoma of Head and Neck; Colo-rectal Cancer; Non Small Cell Lung Cancer; Transitional Cell Carcinoma of the Bladder; Other Solid Tumors; Clear Cell Renal Cell Carcinoma
HiberCell, Inc.
 2022-02-23 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-10)

Check the HC-7366 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

HC-7366 selectively binds to and activates general control nonderepressible 2 (GCN2), initiating downstream phosphorylation within the integrated stress response pathway to disrupt cellular metabolic homeostasis and inhibit protein synthesis. This impairment of metabolic adaptation suppresses tumor proliferation and metastatic dissemination, providing therapeutic rationale for its clinical evaluation in renal cell carcinoma, acute myeloid leukemia, and other advanced solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.