Clinical Trials

Numerous clinical trials, spanning Early Phase 1 through Phase 3, evaluate monomethyl auristatin E (MMAE)-based antibody-drug conjugates across oncology indications including HER2-positive breast cancer, urothelial carcinoma, castration-resistant prostate cancer, gastric adenocarcinoma, and hematologic malignancies. Featuring recruitment statuses ranging from not yet recruiting to completed, research is driven by pharmaceutical sponsors such as Merck, RemeGen, and LaNova alongside academic institutions like Charite University. These studies primarily assess therapeutic efficacy, pharmacokinetics, and safety profiles across targeted patient populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07576998 NOT_YET_RECRUITING
Chronic Subdural Hematomas
Microvention-Terumo, Inc.
 2026-12-31
NCT07497919 NOT_YET_RECRUITING
Penile Cancer
Fudan University
 2026-05-01 PHASE2
NCT06347796 RECRUITING
Chronic Subdural Hematoma
The University of Texas Medical Branch, Galveston
 2024-11-01
NCT07729098 NOT_YET_RECRUITING
Chronic Subdural Hematoma
Dheeraj Gandhi
 2027-01-01 PHASE1
NCT07662863 NOT_YET_RECRUITING
Bladder Cancer; Metastatic Urothelial Carcinoma; Urothelial Carcinoma; Peripheral Neuropathy
Fudan University
 2026-07-15 PHASE2
NCT07628855 NOT_YET_RECRUITING
HNPCC
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
 2026-05-14 PHASE2
NCT07757113 NOT_YET_RECRUITING
Chronic Subdural Hematoma; Stroke; Middle Meningeal Artery Embolization
Sanford Health
 2026-09
NCT07198659 RECRUITING
Unresectable Pancreatic Cancer
The First Affiliated Hospital of Air Force Medicial University
 2025-07-14 EARLY_PHASE1
NCT07223008 RECRUITING
Migraine; Chronic Migraine Headache; Refractory Migraine
Johns Hopkins University
 2026-04-24
NCT06014658 RECRUITING
Cancer
MBrace Therapeutics
 2023-11-07 PHASE1; PHASE2
NCT05395533 ACTIVE_NOT_RECRUITING
CD20-positive B-cell Non-Hodgkin Lymphoma
Zhejiang Teruisi Pharmaceutical Inc.
 2020-09-08 PHASE1
NCT05898373 UNKNOWN
Salivary Gland Cancer
Peking Union Medical College
 2023-06-07 PHASE1; PHASE2
NCT04280341 UNKNOWN
HER2-Positive Solid Tumors
Peking University
 2020-06-03 PHASE1
NCT05134519 UNKNOWN
Breast Cancer; HER2-positive Breast Cancer
Xijing Hospital
 2021-11-26 PHASE2
NCT03500380 UNKNOWN
Breast Neoplasms; Breast Diseases; Capecitabine; HER2-positive Breast Cancer; HER2 Positive Breast Carcinoma; HER2-positive Advanced Breast With Liver Metastases
RemeGen Co., Ltd.
 2018-04-24 PHASE2; PHASE3
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
NCT06227156 Recruiting
Castration-resistant Prostate Cancer
RemeGen Co. Ltd.
 2024-04-08 Phase 1
NCT06265727 Recruiting
Solid Tumor Adult
Corbus Pharmaceuticals Inc.|CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd.
 2024-04-01 Phase 1|Phase 2
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
NCT05601401 UNKNOWN
Salivary Gland Tumors
Peking Union Medical College Hospital
 2022-03-31 PHASE2
NCT05043987 WITHDRAWN
Pancreatic Cancer; Gastric Cancer
Conjupro Biotherapeutics, Inc.
 2022-11-16 PHASE1
NCT04073602 COMPLETED
Urothelial Carcinoma
RemeGen Co., Ltd.
 2019-08-19 PHASE2
NCT03556345 COMPLETED
Gastric Cancer; HER2 Overexpressing Gastric Carcinoma
RemeGen Co., Ltd.
 2018-07-10 PHASE2
NCT03281824 COMPLETED
HER2-positive Breast Cancer
Alteogen, Inc.
 2018-01-11 PHASE1
NCT03507166 COMPLETED
Urothelial Carcinoma; Advanced Cancer
RemeGen Co., Ltd.
 2017-12-28 PHASE2
NCT01950364 COMPLETED
Hodgkin Lymphoma; Anaplastic Large-cell Lymphoma
Millennium Pharmaceuticals, Inc.
 2013-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-08)

Check the MMAE (Monomethyl auristatin E) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Monomethyl auristatin E (MMAE) specifically binds to tubulin and inhibits microtubule polymerization, thereby disrupting mitotic spindle assembly and arresting the cell cycle at the G2/M phase to induce apoptosis. This potent cytotoxic mechanism forms the payload basis of targeted antibody-drug conjugates evaluated in clinical trials for inhibiting tumor proliferation in malignancies such as HER2-positive breast cancer, gastric adenocarcinoma, and urothelial carcinoma.

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.