AST5902 trimesylate Clinical Trials

Size	Price	Qty
5mg	USD 479
25mg	USD 1,437

Clinical Trials

Multiple clinical trials in Phase 1 development evaluate the therapeutic and pharmacokinetic profiles of this compound and its parent drug. Sponsored by industry entities including ArriVent BioPharma Inc. and Allist Pharmaceuticals Inc., these studies encompass both completed pharmacokinetic evaluations and active, recruiting trials. The research assesses safety, biotransformation, food effect, and antitumor activity in healthy male volunteers and patients with advanced or metastatic non-small cell lung cancer harboring EGFR exon 20 mutations, HER2 exon 20 mutations, or uncommon EGFR variants such as G719X and S768I.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05364073	Recruiting	Non-Small Cell Lung Cancer (NSCLC)\|Metastatic Non-Small Cell Lung Cancer\|Advanced Non-Small Cell Lung Cancer\|HER2 Exon 20 Mutations\|EGFR Exon 20 Mutations\|EGFR Uncommon Mutations Including G719X and S768I	ArriVent BioPharma Inc.	2022-06-30	Phase 1
NCT03941340	Completed	Healthy Male Volunteers	Allist Pharmaceuticals Inc.	2019-04-08	Phase 1
NCT03926182	Completed	Healthy Male Volunteers	Allist Pharmaceuticals Inc.	2019-02-19	Phase 1

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

Check the AST5902 trimesylate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AST5902 trimesylate acts as an irreversible, highly selective epidermal growth factor receptor (EGFR) inhibitor that binds covalently to the kinase domain, suppressing downstream oncogenic signaling cascades and inhibiting tumor cell proliferation. This targeted inhibition of mutant EGFR pathways provides the mechanistic basis for suppressive antitumor activity in non-small cell lung cancer characterized by EGFR and HER2 exon 20 or uncommon mutations.

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>).