Clinical Trials

A Phase 1 clinical trial sponsored by M.D. Anderson Cancer Center is actively recruiting patients to evaluate the safety, pharmacokinetics, and preliminary anti-tumor activity of IACS-6274. This early-phase study targets advanced or refractory malignancies, including solid neoplasms, endometrial carcinoma, cutaneous melanoma, ovarian adenocarcinomas, head and neck squamous cell carcinoma, and chondrosarcoma. By focusing on these hard-to-treat cancers, the investigation seeks to establish the therapeutic viability and clinical safety profile of this glutaminase inhibitor.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05039801 RECRUITING
Advanced Endometrial Carcinoma; Advanced Head and Neck Squamous Cell Carcinoma; Advanced Malignant Solid Neoplasm; Advanced Melanoma; Advanced Ovarian Clear Cell Adenocarcinoma; Chondrosarcoma; Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Pathologic Stage III Cutaneous Melanoma AJCC v8; Pathologic Stage IIIA Cutaneous Melanoma AJCC v8; Pathologic Stage IIIB Cutaneous Melanoma AJCC v8; Pathologic Stage IIIC Cutaneous Melanoma AJCC v8; Pathologic Stage IIID Cutaneous Melanoma AJCC v8; Pathologic Stage IV Cutaneous Melanoma AJCC v8; Recurrent Ovarian High Grade Serous Adenocarcinoma; Refractory Endometrial Carcinoma; Refractory Head and Neck Squamous Cell Carcinoma; Refractory Melanoma; Refractory Ovarian Clear Cell Adenocarcinoma; Refractory Ovarian High Grade Serous Adenocarcinoma; Stage III Ovarian Cancer AJCC v8; Stage III Uterine Corpus Cancer AJCC v8; Stage IIIA Ovarian Cancer AJCC v8; Stage IIIA Uterine Corpus Cancer AJCC v8; Stage IIIA1 Ovarian Cancer AJCC v8; Stage IIIA2 Ovarian Cancer AJCC v8; Stage IIIB Ovarian Cancer AJCC v8; Stage IIIB Uterine Corpus Cancer AJCC v8; Stage IIIC Ovarian Cancer AJCC v8; Stage IIIC Uterine Corpus Cancer AJCC v8; Stage IIIC1 Uterine Corpus Cancer AJCC v8; Stage IIIC2 Uterine Corpus Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Uterine Corpus Cancer AJCC v8; Stage IVA Ovarian Cancer AJCC v8; Stage IVA Uterine Corpus Cancer AJCC v8; Stage IVB Ovarian Cancer AJCC v8; Stage IVB Uterine Corpus Cancer AJCC v8
M.D. Anderson Cancer Center
2021-09-30 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-01)

Check the IACS-6274 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

IACS-6274 acts as a potent, selective inhibitor of glutaminase that binds the enzyme to block the conversion of glutamine into glutamate, thereby disrupting downstream TCA cycle replenishment, mitochondrial bioenergetics, and cellular redox balance. This metabolic deprivation starves malignant cells of essential energy precursors and induces cell proliferation arrest, providing the biochemical basis for its evaluated antineoplastic efficacy in advanced solid tumors such as refractory melanoma, ovarian, and endometrial carcinomas.

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>).

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