PharmaMar initiates a phase II “Basket” trial for PM1183 in selected advanced solid tumors
The transcription inhibitor PM1183 will be tested in up to 225 cancer patients in the US and Europe. The primary endpoint will assess the overall response rate (ORR), which is the proportion of patients that have either a complete or partial response, obtained with PM1183 in each of these tumors. The secondary objectives of the study will include endpoints to better characterize the activity of PM1183, such as duration of response, clinical benefit, progression-free survival (PFS) and overall survival at one year. In addition, this study will evaluate the safety and pharmacological profile of PM1183 in these patients, as well as pharmacogenetic and pharmacogenomics analyses to explore individual variability and predictive factors of drug response, respectively.
“This basket trial will help us identify in which advanced cancers with limited or no treatment options, PM1183 will be more effective and will provide valuable data for the therapeutic development of this drug in different tumors,” said Dr. Arturo Soto, Clinical Development Director, PharmaMar.