Zidesamtinib Clinical Trials

Size	Price	Qty
5mg	USD 597
25mg	USD 1,790

Clinical Trials

Multiple clinical trials sponsored by Nuvalent Inc. are evaluating the safety and efficacy of zidesamtinib (NVL-520) in patients with locally advanced or metastatic solid tumors, particularly ROS1-positive non-small cell lung cancer. Key protocols comprise the Phase 1/2 ARROS-1 trial evaluating dose escalation and expansion, alongside an expanded access treatment program. Active studies are currently recruiting or available, reflecting ongoing clinical development for this target indication.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05118789	RECRUITING	Locally Advanced Solid Tumor; Metastatic Solid Tumor	Nuvalent Inc.	2022-01-04	PHASE1; PHASE2
NCT05118789	Recruiting	Locally Advanced Solid Tumor\|Metastatic Solid Tumor	Nuvalent Inc.	2022-01-04	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-10-24)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zidesamtinib selectively binds to and inhibits wild-type ROS1 tyrosine kinase with sub-nanomolar potency (IC50 = 0.7 nM), thereby blocking downstream oncogenic signal transduction cascades and impairing tumor cell proliferation and survival. By penetrating the blood-brain barrier and disrupting intracellular ROS1 kinase activity, this targeted inhibition suppresses oncogenic growth in ROS1-positive non-small cell lung cancer and advanced solid tumors.

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>).