Sovilnesib (AMG 650) Clinical Trials

Size	Price	Qty
5mg	USD 307
25mg	USD 919

Clinical Trials

Multiple clinical trials evaluate the selective KIF18A inhibitor Sovilnesib across early-phase oncology studies, specifically Phase I and Phase Ib investigations sponsored by industry partners such as Volastra Therapeutics and Amgen. These dose-exploration and dose-optimization studies focus on subjects presenting with advanced solid tumors, high-grade serous ovarian adenocarcinoma, fallopian tube cancer, primary peritoneal carcinoma, and cancers characterized by chromosomal instability. Encompassing completed, recruiting, and active, not recruiting stages, several clinical trials aim to assess the compound's safety, pharmacokinetics, and clinical efficacy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06084416	ACTIVE_NOT_RECRUITING	High Grade Serous Adenocarcinoma of Ovary; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; Chromosomal Instability	Volastra Therapeutics, Inc.	2024-04-04	PHASE1
NCT06084416	Recruiting	High Grade Serous Adenocarcinoma of Ovary\|Fallopian Tube Cancer\|Primary Peritoneal Carcinoma\|Chromosomal Instability	Volastra Therapeutics Inc.	2024-04-04	Phase 1
NCT04293094	Completed	Advanced Solid Tumors	Volastra Therapeutics Inc.\|Amgen	2020-03-11	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-10-20)

Check the Sovilnesib (AMG 650) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sovilnesib selectively binds to and inhibits the kinesin-like protein KIF18A, thereby disrupting mitotic spindle assembly and chromosome alignment during cell division. This persistent mitotic impairment induces prolonged cell cycle arrest and selective apoptosis in tumor cells exhibiting chromosomal instability, offering target-directed anti-neoplastic activity for clinical indications such as high-grade serous ovarian 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>).