Promontory Therapeutics has treated its first patients in France as part of the ongoing Phase II clinical trial of PT-112 in patients with late-stage metastatic castration-resistant prostate cancer (mCRPC).
The Phase II proof-of-concept study has the objective of characterising the benefit-risk ratio and selecting the optimal dose regimen for pivotal development of PT-112, in line with the FDA’s Project Optimus.
In addition to proof of concept via safety and efficacy findings among late-stage metastatic patients, the study aims to generate meaningful supportive data via correlative research, for example on immune activation by PT-112 monotherapy, and by examining circulating tumour cell reductions.
Within France, the study is being led by primary investigator Dr Karim Fizazi, Medical Oncologist at Gustave Roussy, and Professor of Oncology at the University of Paris-Saclay. Gustave Roussy and HIA Bégin, the latter led by investigator Carole Helissey, MD, are the first two of ten sites across France that will recruit patients for the study.
“Dr Fizazi is a global leader in prostate cancer and under his guidance, we are looking forward to treating mCRPC patients in France and further understanding the potential impact of PT-112 on these late-stage mCRPC patients, who currently have few options for life-prolonging therapy,” said Promontory Therapeutics Chief Medical Officer Johan Baeck.
“We are very pleased to begin treating patients in France with advanced, metastatic prostate cancer, as part of the ongoing Phase II clinical trial of PT-112,” commented Dr Fizazi. “Based upon early data, PT-112 has the potential to offer a promising form of immune activation to such patients, who generally do not have effective immunotherapy options to date.”
Edited by: Diana Spencer, Senior Digital Content Editor, Drug Discovery World