AC480 (BMS-599626) Clinical Trials

Size	Price	Qty
5mg	USD 170
1g	USD 3,900

Clinical Trials

Multiple Phase I clinical trials sponsored by pharmaceutical companies and academic institutions have evaluated AC480 (BMS-599626) in advanced solid tumors, malignant glioma, HER2-expressing malignancies, and metastatic cancers. These studies investigated dosing regimens, safety, and pharmacokinetic parameters across the target populations. While several clinical trials were successfully completed, a clinical trial was withdrawn prior to completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01245543	Withdrawn	Solid Tumors	Daiichi Sankyo	2010-11	Phase 1
NCT00979173	Completed	Glioma	Annick Desjardins\|Ambit Biosciences Corporation\|Duke University	2009-11	Phase 1
NCT00093730	Completed	Unspecified Adult Solid Tumor Protocol Specific	Jonsson Comprehensive Cancer Center\|National Cancer Institute (NCI)	2004-08	Phase 1
NCT00095537	Completed	Cancer\|Metastases	Bristol-Myers Squibb	2004-03	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the AC480 (BMS-599626) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AC480 (BMS-599626) potently and selectively binds to human epidermal growth factor receptors HER1 (EGFR) and HER2, thereby inhibiting receptor autophosphorylation, abrogating downstream oncogenic signaling cascades, and suppressing tumor cell proliferation. By inhibiting these dependent growth pathways, this dual receptor block provides the biological rationale for evaluating AC480 in clinical trials targeting HER2-expressing solid tumors, malignant gliomas, and metastatic 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>).