VcMMAE (MC-Vc-PAB-MMAE) Clinical Trials

Size	Price	Qty
5mg	USD 187
25mg	USD 549

Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 3 evaluate antibody-drug conjugates incorporating the VcMMAE drug-linker complex across diverse malignancies, including triple-negative breast cancer, advanced melanoma, recurrent osteosarcoma, castration-resistant prostate cancer, gastric adenocarcinoma, and B-cell acute lymphoblastic leukemia. Sponsored by governmental research bodies such as the National Cancer Institute alongside biopharmaceutical developers including Celldex Therapeutics, RemeGen, and Merck Sharp & Dohme, trial recruitment statuses range from completed evaluations to active studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06395103	Not yet recruiting	B-cell Acute Lymphoblastic Leukemia\|Diffuse Large B-cell Lymphoma\|Burkitt Lymphoma\|Neuroblastoma\|Ewing Sarcoma	Merck Sharp & Dohme LLC	2024-06-04	Phase 1\|Phase 2
NCT06265727	Recruiting	Solid Tumor Adult	Corbus Pharmaceuticals Inc.\|CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd.	2024-04-01	Phase 1\|Phase 2
NCT06227156	Recruiting	Castration-resistant Prostate Cancer	RemeGen Co. Ltd.	2024-04-08	Phase 1
NCT06351020	Not yet recruiting	Locally Advanced or Metastatic GC and GCJ Adenocarcinoma	LaNova Medicines Zhejiang Co. Ltd.\|LaNova Medicines Limited	2024-04-01	Phase 3
NCT01997333	COMPLETED	Metastatic gpNMB Over-expressing Triple Negative Breast Cancer	Celldex Therapeutics	2013-11	PHASE2
NCT02487979	COMPLETED	Recurrent Osteosarcoma	National Cancer Institute (NCI)	2016-02-16	PHASE2
NCT01156753	COMPLETED	Breast Cancer	Celldex Therapeutics	2010-07	PHASE2
NCT00412828	COMPLETED	Unresectable Stage III or Stage IV Melanoma	CuraGen Corporation	2006-06	PHASE1; PHASE2
NCT00704158	COMPLETED	Breast Cancer	CuraGen Corporation	2008-06	PHASE1; PHASE2

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

Check the VcMMAE (MC-Vc-PAB-MMAE) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Following lysosomal cleavage of the cathepsin-sensitive valine-citrulline linker inside target cells, the freed monomethyl auristatin E payload selectively binds to tubulin and inhibits microtubule polymerization, triggering G2/M phase cell cycle arrest and apoptosis. This mechanistically driven cytotoxicity produces sustained tumor growth inhibition across clinical indications such as breast cancer, advanced melanoma, and gastric adenocarcinoma.

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>).