Clinical Trials

A multi-center, open-label Phase 1/Phase 2 clinical trial sponsored by Vivace Therapeutics, Inc. is currently recruiting adult patients with locally advanced or metastatic solid tumors, specifically targeting mesothelioma and non-small cell lung cancer (NSCLC). This active study evaluates VT3989 administered either as a single agent or in combination therapies to establish the drug's safety profile, pharmacokinetics, and preliminary therapeutic efficacy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04665206 RECRUITING
Solid Tumor, Adult; Mesothelioma; NSCLC
Vivace Therapeutics, Inc
2021-03-24 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-02)

Check the VT3989 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

VT3989 is an orally bioavailable inhibitor that selectively targets and disrupts TEAD auto-palmitoylation, thereby blocking the crucial interaction between TEAD transcription factors and the oncogenic co-activator yes-associated protein (YAP). By preventing YAP/TAZ-TEAD complex formation and suppressing downstream transcriptional signaling, VT3989 inhibits tumor cell proliferation and survival, demonstrating therapeutic relevance for adult patients with advanced solid tumors, mesothelioma, and non-small cell lung cancer.

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>).

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