ETC-159 Clinical Trials

Size	Price	Qty
5mg	USD 147
100mg	USD 792

Clinical Trials

Multiple Phase I clinical trials are evaluating the safety, tolerability, and preliminary activity of ETC-159, administered alone or in combination with pembrolizumab, in patients with advanced solid tumors and MSS/pMMR advanced, platinum-resistant ovarian cancer. Sponsored by the Experimental Drug Development Centre (EDDC) at A*STAR Research Entities in partnership with PPD, alongside the National University Hospital, Singapore, these studies currently range in status from active, not recruiting to actively recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06513624	RECRUITING	With MSS/pMMR Advanced, Platinum-resistant Ovarian Cancer	National University Hospital, Singapore	2024-12-09	PHASE1
NCT02521844	Active not recruiting	Solid Tumors	EDDC (Experimental Drug Development Centre) A*STAR Research Entities\|PPD	2015-10	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-07-25)

Check the ETC-159 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ETC-159 functions as a potent inhibitor of porcupine, an enzyme essential for the post-translational O-palmitoylation and functional secretion of Wnt proteins, thereby suppressing downstream Wnt/β-catenin transcriptional activation and cellular proliferation. This targeted inhibition disrupts Wnt-driven oncogenic signaling pathways, offering a compelling clinical strategy for treating patients with advanced solid tumors and platinum-resistant ovarian 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>).