Clinical Trials

Volastra Therapeutics, Inc. is currently sponsoring a clinical trial evaluating VLS-1488, a targeted oral KIF18A inhibitor, across various advanced solid tumors and malignancies exhibiting chromosomal instability. This actively recruiting Phase 1/2 study targets conditions including high-grade serous ovarian adenocarcinoma, triple-negative breast cancer, squamous non-small-cell lung cancer, head and neck carcinoma, uterine cancers, and endometrial cancer to evaluate safety, tolerability, and preliminary efficacy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05902988 RECRUITING
Advanced Solid Tumor; High Grade Serous Adenocarcinoma of Ovary; Squamous Non-small-cell Lung Cancer; Triple Negative Breast Cancer; Head and Neck Squamous Cell Carcinoma; Ovarian Carcinosarcoma; Uterine Carcinosarcoma; Uterine Serous Carcinoma; Endometrium Cancer; Chromosomal Instability
Volastra Therapeutics, Inc.
 2023-10-18 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2025-11-04)

Check the VLS-1488(KIF18A-IN-6 ) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

VLS-1488 functions as a potent, oral inhibitor of the mitotic kinesin motor protein KIF18A with an IC50 of 0.016 μM, binding the target to disrupt kinetochore microtubule spindle fiber dynamics during cell division. By suppressing KIF18A-mediated mitotic control, the compound induces selective cell death in cancer cells with high chromosomal instability, offering a potential therapeutic intervention for advanced solid tumors such as triple-negative breast cancer and high-grade serous ovarian adenocarcinoma.

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>).

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Note: Technical data last updated: Sep 1, 2026.