AMG319 Clinical Trials

Size	Price	Qty
5mg	USD 127

Clinical Trials

A clinical trial evaluated orally administered AMG319 as a neoadjuvant therapy in oncology. Sponsored by Cancer Research UK, this Phase 2 study focused on patients with human papillomavirus (HPV)-positive or HPV-negative head and neck squamous cell carcinoma of the hypopharynx, oropharynx, oral cavity, supraglottis, or larynx. According to trial records, the recruitment status for this evaluation is listed as terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02540928	Terminated	Human Papillomavirus (HPV)\|Positive or Negative Head and Neck Squamous Cell Carcinoma (HNSCC) of the Hypopharynx Oropharynx Oral Cavity Supraglottis or Larynx	Cancer Research UK	2015-10	Phase 2

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

Check the AMG319 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AMG319 selectively binds to phosphoinositide 3-kinase delta (PI3Kδ), blocking downstream lipid kinase activity and inhibiting AKT/mTOR pathway signaling. This biochemical block impairs leukocyte proliferation and tumor cell survival, supporting its clinical exploration in human papillomavirus-positive and -negative head and neck squamous cell carcinoma.

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>).