NCT01764009

Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma

Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open-label Phase I/II Clinical Trial - The AIMM Study (AMEP In Metastatic Melanoma)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Valerio Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the present trial is: * to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma. * to determine the local and general safety of intramuscular electrotransferred Plasmid AMEP * to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP

Detailed description

In this open-label, multicentre, dose escalation phase I study, successive cohorts of 3 patients suffering from advanced or metastatic melanoma will be electrotransferred increasing doses of Plasmid AMEP into muscle. Treatment will be repeated every 28 days until progression or limiting toxicity. Consecutive cohorts of 3 to 6 patients will be treated with increasing doses of Plasmid AMEP at three dose levels: 0.25 mg, 1 mg and 4 mg according to an adapted 3+3 design. There will be no intra-patient dose escalation.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	naked DNA coding for protein AMEP	injections 28days interval of 3 increasing doses of plasmid with electrotransfer

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-12-01
• Completion: 2014-03-01
• First posted: 2013-01-09
• Last updated: 2015-09-11

Locations

4 sites across 2 countries: France, Slovenia