Clinical Trials

In a Phase 1 clinical trial sponsored by Seagen Inc., SGN-2FF was evaluated in patients with various advanced solid malignancies, including non-small-cell lung, renal cell, breast, head and neck, and gastrointestinal cancers. This early-phase study aimed to investigate the initial safety, tolerability, and therapeutic potential of the compound across these oncological conditions. Official clinical registries list the recruitment status for this trial as terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02952989 TERMINATED
Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Breast Neoplasms; Urinary Bladder Neoplasm; Carcinoma, Squamous Cell of Head and Neck; Colorectal Neoplasms; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma
Seagen Inc.
 2017-02-23 PHASE1

(data from https://clinicaltrials.gov, updated on 2019-07-19)

Check the SGN-2FF product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SGN-2FF acts as a small-molecule inhibitor of fucosyltransferase, blocking the intracellular enzymatic transfer of fucose to target glycoproteins and thereby impairing downstream cell-surface receptor signaling pathways. By disrupting protein fucosylation necessary for oncogenic signaling and cellular adhesion, SGN-2FF suppresses tumor cell survival and proliferation, demonstrating therapeutic relevance in the treatment of advanced solid tumors such as non-small-cell lung carcinoma, renal cell carcinoma, and breast neoplasms.

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.