Date: 2014-02-12
Type of information:
phase: 1-2
Announcement: enrollment of the first patients
Company: Ganymed Pharmaceuticals (Germany)
Product: IMAB027
Action mechanism: IMAB027 is a first-in-class monoclonal antibody against Claudin-6 (CLDN6), a tight junction protein which is absent from healthy adult tissues but is present in a wide range of non-hematological cancers such as ovarian, testicular, uterine, and lung cancers. The unparalleled specificity of CLDN6 to cancer cells potentially makes IMAB027 a high-precision therapeutic that efficiently kills cancer cells without harming healthy non-cancerous cells.
Disease: ovarian cancer
Therapeutic area: Cancer - Oncology
Country: Germany, Belgium, Russia, Ukraine
Trial details: The OVAR trial will enroll 72 patients with advanced ovarian cancer who are resistant to or have relapsed following standard-of-care treatment with platinum-based chemotherapy agents. Patients will be selected according to the expression level of CLDN6 in their tumor biopsies. In the Phase I portion of the trial, patients will receive escalating doses of IMAB027 to assess safety, tolerability and determine the recommended Phase II dose. Upon full review and approval by an independent Data Safety Monitoring Board, the Phase II portion of the trial will be initiated to investigate the anticancer activity of IMAB027.
Latest
news: * On February 12, 2014, Ganymed Pharmaceuticals has announced that the first patients are being enrolled and are starting treatment in a Phase I/II OVAR clinical trial to assess the safety, tolerability, and efficacy of IMAB027 as single agent for the treatment of advanced ovarian cancer. IMAB027 is a highly specific monoclonal antibody targeting the tight junction protein Claudin-6 (CLDN6). The trial is being conducted in Germany, Belgium, Russia, and Ukraine.The company anticipates completing the trial in 2016.
