Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel With Trastuzumab in Patients With HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy
The purpose of this study is to determine the effects of MM-111 on carcinomas of the distal esophagus, gastroesophageal (GE) Junction and stomach. The study also aims to learn more about the safety and effectiveness of the study drug. MM-111 is an investigational drug called a bi-specific single chain antibody. MM-111 is investigational because it is not approved by the FDA for treatment of your cancer. A bi-specific single chain antibody is a type of protein made in a laboratory. An antibody is a type of protein that is made in the body in response to a foreign substance. Antibodies can locate and bind to substances in the body, including tumor cells. MM-111 is an antibody that binds to specific proteins found on the surface of cells. These proteins, ErbB2 and ErbB3 (also known as HER2 and HER3), are involved with cell growth. In laboratory studies, MM-111 has been shown to bind to ErbB2 and ErbB3 and interfere with tumor cell growth.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : MM-111
- drug : Trastuzumab
- drug : Paclitaxel
Phase: Phase 2
Ages Eligible For Study:
- Patients must have documentation of histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the distal esophagus, GE junction or stomach - Patients must have documentation of histologically or cytologically confirmed HER2 expression - Patients must be ?18 years of age - Patients must have ECOG PS of 0, 1, or 2 - Patients must have adequate hematologic status, renal and hepatic function