Cristal Therapeutics has begun patient dosing in its Phase 2a trial evaluating CPC634 — the chemotherapy docetaxel, delivered in nanoparticles — in patients whose ovarian cancer has become resistant to platinum-based chemotherapy.
The exploratory study (2018-002117-36) is expected to include 27 patients across 10 clinical sites in the United Kingdom, Belgium, Netherlands, and Spain. Eligible participants received a maximum of three prior therapies for platinum-resistant disease, one of which could have included a taxane such as Taxotere (docetaxel).
“Treatment of platinum-resistant ovarian cancer is an area of high unmet medical need and this trial will give us the opportunity to assess both the therapeutic efficacy of CPC634 and its potential to reduce toxic systemic side effects, such as neutropenia and alopecia seen with the current standard of care,” Jonathan Ledermann, MD, professor at UCL Cancer Institute, London, and principal investigator of the trial, said in a press release.
CPC634, developed with Cristal’s proprietary CriPec technology, consists of tiny degradable particles that deliver the chemotherapy agent docetaxel specifically into cancer cells.
CriPec nanoparticles are custom-made particles that improve the stability of the compounds loaded inside them, while allowing their delivery at a specific site and with a tailored rate of release. Thus, CPC634 is expected to accumulate at the tumor site and increase docetaxel’s therapeutic activity while reducing systemic toxicity.
Results from a Phase 1 trial called NAPOLY (NCT02442531) showed that CPC634 can be administered at therapeutic dose levels that are safe and well-tolerated. The trial included 33 patients with advanced solid tumors in clinical centers in Belgium and the Netherlands.
“CPC634 also demonstrated encouraging signs of efficacy and reduction in systemic side effects commonly seen with docetaxel,” said Joost Holthuis, PhD, CEO and co-founder of Cristal Therapeutics.
The ongoing Phase 2 trial now aims to determine the rate of response, partial or complete, to intravenous CPC634. Secondary measures include safety and tolerability, how long patients live without signs of disease worsening — measured through rising levels of CA-125, a biomarker of ovarian cancer progression — duration of response, and disease control rate.