PRN1371 Clinical Trials

Size	Price	Qty
2mg	USD 147

Clinical Trials

A clinical trial evaluated the therapeutic potential of PRN1371, an FGFR kinase inhibitor, in adult patients with advanced solid tumors, specifically targeting metastatic urothelial carcinoma and malignancies of the renal pelvis and ureter. Initiated by Principia Biopharma, a Sanofi company, this industry-sponsored Phase 1 open-label dose-escalation study aimed to establish safety and preliminary efficacy. However, recruitment for this study was ultimately terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02608125	Terminated	Solid Tumors\|Metastatic Urothelial Carcinoma & Renal Pelvis & Ureter	Principia Biopharma a Sanofi Company	2015-10-28	Phase 1

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

Check the PRN1371 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PRN1371 acts as a potent, irreversible covalent inhibitor of fibroblast growth factor receptors 1 through 4 (FGFR1–4), selectively binding the receptor kinase domains to block autophosphorylation and suppress downstream pro-survival signaling cascades. By inhibiting FGFR-driven cell proliferation and survival, this pharmacological blockade disrupts tumor growth, providing a therapeutic rationale for targeting advanced solid tumors such as metastatic urothelial carcinoma and malignancies of the renal pelvis and ureter.

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>).