Date: 2015-07-15
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Amgen (USA - CA)
Product: talimogene laherparepvec
Action
mechanism: oncolytic virus/immunotherapy product. Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors (but not normal tissue) and to initiate an immune response to target cancer cells that have metastasized. Talimogene laherparepvec was designed to work in two important and complementary ways. First, it is injected directly into tumors where it replicates inside the tumor's cells causing the cell to rupture and die in a process called lysis. The rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a system-wide immune response where white blood cells are able to seek out and target cancer that has spread throughout the body.
Disease: hepatocellular carcinoma
Therapeutic area: Cancer - Oncology
Country: Spain, Switzerland, USA
Trial
details: Thi phase 1, multicenter, open-label trial is evaluating the safety of talimogene laherparepvec, injected intrahepatically, into liver tumors with known progression in subjects with hepatocellular carcinoma and subjects with liver metastases from breast adenocarcinoma, colorectal adenocarcinoma, gastroesophageal cancer (adenocarcinoma or squamous cell carcinoma), melanoma, non-small cell lung cancer, or clear cell renal cell carcinoma. The study consists of 2 parts and 2 groups. Part 1 is a 3+3 dose escalation consisting of 3 sequential dose cohorts each administering talimogene laherparepvec in increasing dose concentrations and dose volumes. In Part 1, the Maximum Tolerated Dose determination of non-hepatocellular carcinoma liver metastases (Group A) will be evaluated separately from hepatocellular carcinoma (Group B), and each dose cohort will need to be deemed safe for non-hepatocellular carcinoma subjects before it will be administered in hepatocellular carcinoma subjects. Part 2 consists of expansion cohorts administering the Maximum Tolerated Dose of talimogene laherparepvec determined from Part 1 for Groups A (non-hepatocellular carcinoma) and B (hepatocellular carcinoma) to approximately 10 subjects for each tumor type. (NCT02509507)
Latest
news: * On July 15, 2015, a Phase I trial sponsored by Amgen was published on the NIH website ClinicalTrials.gov for talimogene laherparepvec and is currently recruiting participants.
