Altiratinib Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 297

Clinical Trials

A clinical trial evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of the investigational multi-kinase inhibitor altiratinib. Sponsored by Deciphera Pharmaceuticals LLC, this Phase 1 ascending-dose study targeted adult patients presenting with locally advanced or metastatic solid tumors, including cancers harboring MET or TRK genomic alterations. However, recruitment for this early-phase investigation was officially terminated, and no additional clinical trials are currently registered for this compound.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02228811	Terminated	Locally Advanced Tumors\|Metastatic Solid Tumors\|Cancers With MET Genomic Alterations\|Cancers With TRK Genomic Alterations	Deciphera Pharmaceuticals LLC	2014-06	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Altiratinib selectively binds to and inhibits TRK family kinases, MET, TIE2, and VEGFR2, thereby blocking downstream oncogenic phosphorylation cascades and intracellular signal transduction. This multi-kinase blockade suppresses tumor cell proliferation, survival, and angiogenesis, providing a mechanistic rationale for targeting locally advanced or metastatic solid tumors driven by MET or TRK genomic alterations.

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>).