NCT01222624

PankoMab-GEX™: Phase 1 Dose Escalation Study

Phase I Dose Escalation Study Evaluating the Safety and Tolerability of PankoMab-GEX™ in Patients With Advanced, TA-MUC1 Positive Solid Malignancies Who Are Not Longer Eligible for Standard Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Glycotope GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, open label, dose escalating, multicenter, phase I study measuring the safety, tolerability, and pharmacokinetics of PankoMab-GEX™ after intravenous administration in patients with locally advanced or metastatic solid cancers refractory to standard treatment. The effect of PankoMab-GEX™ on the development of antibodies and tumor response was also evaluated.

Detailed description

Male or female patients of age 18 years or older with a histologically-confirmed, tumor-associated mucin 1 (TA-MUC1) positive, measurable or non-measurable solid tumor who had failed standard therapy and for whom no standard therapy was available. Open-label, non-randomized, inter-patient dose escalation, multi-center study in a 3 + 3 design. Patients received PankoMab-GEX™ treatment until disease progression or until the treatment was no longer tolerated.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	PankoMab-GEX™

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-12-01
• Completion: 2013-05-01
• First posted: 2010-10-18
• Last updated: 2021-05-20

Locations

4 sites across 3 countries: Germany, Italy, Switzerland