Clinical Trials

A clinical trial evaluated the small-molecule inhibitor OTX008 administered subcutaneously as a single agent in patients with advanced solid tumors. Designed as a Phase 1, first-in-human study, the trial aimed to assess the safety, tolerability, and pharmacological profile of the therapy. Sponsored by Oncoethix GmbH, a subsidiary of Merck & Co., Inc., the recruitment status of this industry-sponsored investigation is currently documented as unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01724320 UNKNOWN
Solid Tumors
Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2012-02 PHASE1

(data from https://clinicaltrials.gov, updated on 2012-11-09)

Check the OTX008 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

OTX008 selectively binds to galectin-1 (Gal1), disrupting its interaction with cell surface glycoconjugates and subsequently inhibiting downstream pro-survival and angiogenic signaling pathways. This molecular inhibition suppresses tumor cell proliferation, migration, and endothelial tube formation, demonstrating therapeutic potential against advanced solid tumors.

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.