MMAF (Monomethylauristatin F) Clinical Trials

Size	Price	Qty
5mg	USD 327
25mg	USD 897

Clinical Trials

Multiple clinical trials evaluate the MMAF-containing antibody-drug conjugate belantamab mafodotin for multiple myeloma, including relapsed or refractory forms of the disease. Sponsored by GlaxoSmithKline, these Phase I studies focus on assessing the safety, tolerability, pharmacokinetics, immunogenicity, and clinical activity of monotherapy regimens. Featuring both actively recruiting and completed recruitment statuses, these evaluations support early-phase safety and pharmacokinetic profiling for plasma cell malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04398680	Recruiting	Multiple Myeloma	GlaxoSmithKline	2021-04-20	Phase 1
NCT04398745	Recruiting	Multiple Myeloma	GlaxoSmithKline	2020-10-09	Phase 1
NCT04177823	Completed	Multiple Myeloma	GlaxoSmithKline	2019-12-09	Phase 1

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

Check the MMAF (Monomethylauristatin F) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MMAF (Monomethylauristatin F) selectively binds to tubulin and potently inhibits tubulin polymerization, thereby disrupting microtubule dynamics and inducing cell cycle arrest at the G2/M phase. When delivered as the cytotoxic payload of targeted antibody-drug conjugates, this antineoplastic agent causes apoptotic cell death in targeted cancer cells, providing therapeutic efficacy in the treatment of relapsed or refractory multiple myeloma.

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>).