NCT00635596

Phase I Study of MT110 in Lung Cancer (Adenocarcinoma and Small Cell), Gastric Cancer or Adenocarcinoma of the Gastro-Esophageal Junction, Colorectal Cancer, Breast Cancer, Hormone-Refractory Prostate Cancer, and Ovarian Cancer

An Open-label, Multi-center Dose Escalation Phase I Study to Investigate the Safety and Tolerability of a Continuous Infusion of the Bispecific T-cell Engager (BiTE) MT110 in Locally Advanced, Recurrent or Metastatic Solid Tumors Which Commonly Express EpCAM and Are Not Amenable to Curative Treatment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Amgen Research (Munich) GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I dose escalation study is intended to define the safety, tolerability and maximal tolerable dose (MTD) of MT110 in patients with advanced solid tumors.

Detailed description

MT110 is a bispecific (anti-EpCAM x anti-CD3) T-cell engager (BiTE) designed to link EpCAM (epithelial cell adhesion molecule) expressing cells and T-cells resulting in T-cell activation and a cytotoxic T-cell response against EpCAM+ cells. In vitro and ex-vivo data indicate that EpCAM+ tumor cell lines are sensitive to MT110 mediated cytotoxicity. Furthermore, data from in-vivo experiments with both MT110 and a mouse surrogate molecule (muS110) have confirmed the activity of these molecules in inhibiting the formation of metastases but also against established tumors. In vitro and ex-vivo data suggest that a prolonged presence of the drug in target tissues may result in significant T-cell recruitment, activation and expansion to/in target tissues, potentially resulting in substantial anti-tumor activity in man.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	MT110	MT110 treatment as continuous intravenous infusion over at least 28 days with increasing doses

Timeline

• Start date: 2008-03-01
• Primary completion: 2014-01-01
• Completion: 2015-01-01
• First posted: 2008-03-14
• Last updated: 2015-01-13

Locations

4 sites across 1 country: Germany