MedImmune, a biologics unit of AstraZeneca and Micromet have announced the initiation of a Phase 1 trial of MEDI-565 in patients with advanced gastrointestinal cancers. The Phase 1 dose-escalation study will evaluate the safety, tolerability, and antitumor activity of the product candidate in adult patients with advanced gastrointestinal cancers, with dose escalation in subsequent cohorts based on safety and tolerability. Once the maximum tolerated dose is determined, additional study subjects with refractory colorectal or pancreatic cancer will be enrolled in a dose-expansion phase to further assess the safety and antitumor activity. MedImmune and Micromet are working under a collaboration agreement signed in June 2003. Under the terms of the agreement, development and commercialization will be led by MedImmune in the U.S. and outside of Europe, and by Micromet in Europe.
