Clinical Trials

Multiple clinical trials sponsored by Turning Point Therapeutics Inc. evaluated the investigational oral small-molecule agent TPX-0046 across Phase I and Phase II protocols. Designed to assess safety, tolerability, and preliminary efficacy, these studies targeted adult patients with advanced or metastatic solid tumors, specifically non-small cell lung cancer and medullary thyroid cancer harboring oncogenic RET gene mutations. However, recruitment for these trials has been listed as terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04161391 TERMINATED
Non Small Cell Lung Cancer; Medullary Thyroid Cancer; RET Gene Mutation; Metastatic Solid Tumor; Advanced Solid Tumor
Turning Point Therapeutics, Inc.
 2019-12-06 PHASE1; PHASE2
NCT04161391 Terminated
Non Small Cell Lung Cancer|Medullary Thyroid Cancer|RET Gene Mutation|Metastatic Solid Tumor|Advanced Solid Tumor
Turning Point Therapeutics Inc.
 2019-12-06 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-06-13)

Check the TPX-0046 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TPX-0046 acts as a potent RET and SRC tyrosine kinase inhibitor that binds to the ATP-binding region of RET—including solvent-front mutant forms such as RET G810R—and SRC, thereby suppressing autophosphorylation and blocking downstream oncogenic signaling cascades. This biochemical blockade inhibits cell proliferation and drives apoptotic cell death, demonstrating clinical relevance for treating RET-mutated advanced solid tumors, non-small cell lung cancer, and medullary thyroid 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>).

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