CC-90003 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 470

Clinical Trials

A clinical trial evaluated the covalent small-molecule inhibitor CC-90003 in patients presenting with neoplasm metastasis. Sponsored by Celgene, this open-label, multicenter Phase 1 study assessed the safety, tolerability, and pharmacokinetic properties of the agent. However, recruitment was terminated prior to completion, leaving the clinical investigation of CC-90003 in advanced metastatic malignancies limited to a terminated Phase 1 trial.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02313012	Terminated	Neoplasm Metastasis	Celgene	2015-01-05	Phase 1

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

Check the CC-90003 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CC-90003 acts as a potent, irreversible inhibitor of ERK1/2 with IC50 values in the 10–20 nM range, binding directly to extracellular signal-regulated kinases to block downstream MAPK pathway signaling and suppress cellular proliferation. By disrupting these critical phosphorylation cascades, the compound inhibits oncogenic signal transduction and survival, providing a direct biochemical rationale for its evaluation in patients with neoplasm metastasis.

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>).