Clinical Trials

Multiple clinical trials sponsored by Turning Point Therapeutics, Inc. are evaluating elzovantinib (TPX-0022) in adult patients with advanced or metastatic solid tumors and malignancies harboring MET gene alterations. These Phase 1 and Phase 1/2 studies assess the compound's safety, tolerability, pharmacokinetics, and therapeutic efficacy. Currently, these ongoing trials are recorded as active, not recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03993873 ACTIVE_NOT_RECRUITING
Advanced Solid Tumor; Metastatic Solid Tumors; MET Gene Alterations
Turning Point Therapeutics, Inc.
 2019-09-05 PHASE1
NCT03993873 Active not recruiting
Advanced Solid Tumor|Metastatic Solid Tumors|MET Gene Alterations
Turning Point Therapeutics Inc.
 2019-09-21 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-10-01)

Check the Elzovantinib (TPX-0022) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Elzovantinib (TPX-0022) is an orally bioavailable multi-kinase inhibitor that potently targets mesenchymal-epithelial transition factor (MET), colony-stimulating factor 1 receptor (CSF1R), and SRC tyrosine kinases, thereby interrupting oncogenic downstream signal transduction and modulating the tumor immune microenvironment. By suppressing kinase-driven cellular proliferation, cell survival, and tumor-promoting microenvironmental cues, this agent demonstrates therapeutic relevance for patients with advanced and metastatic solid tumors characterized by MET gene alterations.

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.