NCT02194426

First-in-human Study to Investigate the Safety, Tolerability and Blood Levels of the Test Drug MP0250 in Cancer Patients

A Phase I Multi-centre, Open-label, Repeated-dose, Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MP0250 in Patients With Advanced Solid Tumours

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Molecular Partners AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is looking at a new DARPin® drug candidate, called MP0250. There is evidence from preclinical studies that MP0250 may be effective in the treatment of cancer. This is the first study of MP0250 in humans and its main purpose is to test its safety and tolerability in patients with cancer. This study will also examine how the drug is changed by and removed from the body and look for indicators that the drug may be effective against cancer. This study will test several different dose levels of the study drug to determine the safety and tolerability profile of the drug.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	MP0250	Intravenous application by infusion of MP0250 at up to six dose levels, every other week for up to 24 infusions.

Timeline

• Start date: 2014-07-01
• Primary completion: 2018-02-20
• Completion: 2018-02-20
• First posted: 2014-07-18
• Last updated: 2019-08-07

Locations

4 sites across 3 countries: Spain, Switzerland, United Kingdom