Tinostamustine(EDO-S101) Clinical Trials

Size	Price	Qty
1mg	USD 147
5mg	USD 427

Clinical Trials

A Phase 1 open-label, non-randomized clinical trial is evaluating tinostamustine (EDO-S101) in combination with nivolumab to assess its safety, tolerability, and recommended dosing in patients with malignant melanoma. Sponsored by Markus Joerger from the Cantonal Hospital of St. Gallen, the study currently has an unknown recruitment status. This research aims to characterize the preliminary clinical profile and therapeutic feasibility of tinostamustine in advanced dermatological oncology settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03903458	Unknown status	Malignant Melanoma	Markus Joerger\|Cantonal Hospital of St. Gallen	2019-03-07	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Tinostamustine(EDO-S101) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tinostamustine (EDO-S101) acts as a first-in-class alkylating deacetylase inhibitor that simultaneously targets Class I and Class II histone deacetylases (HDACs) while inducing DNA cross-linking, which disrupts chromatin structure, suppresses deacetylase activity, and triggers apoptotic signaling in malignant cells. By simultaneously inducing double-strand DNA damage and epigenetic modification, tinostamustine exerts potent cytotoxic effects that inhibit tumor cell proliferation and survival in patients with malignant melanoma.

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>).