Preliminary data from a Phase 1 multiple ascending dose study in 21 patients with relapsed/refractory B cell Non-Hodgkin Lymphoma and advanced solid malignancies supports initiation of a Phase 2a expansion study
The maximum tolerated dose has not yet been reached, therefore dose escalation continues in patients with advanced solid tumors
The expansion portion of the study will evaluate the clinical activity of PCLX-001 in patients and further characterize the safety, tolerability, and pharmacokinetic profile of PCLX-001
Pacylex is excited to announce the first patient has been dosed in a Phase 2a expansion study in patients with relapsed/refractory B-cell Non-Hodgkin Lymphoma (R/R NHL).
Our Phase 1 multiple ascending dose (MAD) clinical trial evaluating PCLX-001 monotherapy in patients with R/R NHL or advanced solid tumors successfully completed six dose escalations without any dose-limiting toxicities (DLTs) and reached a drug exposure level expected to show clinical activity. Three patients with advanced solid tumors in the highest dose level are continuing to receive PCLX-001.
We received a No Objection Letter from Health Canada earlier this year to initiate the expansion cohort, designed to evaluate a potential Phase 2 dose in patients with R/R NHL. Four Canadian clinical sites have been activated and the first patient has been dosed. The expansion study will enroll up to 20 patients to assess the preliminary clinical activity of PCLX-001.
“The first stage of this first-in-human study assessed the safety of PCLX-001 with repeated dosing. We now transition our clinical investigations from primarily establishing safety to both safety and efficacy at a potential Phase 2 dose,” said Dr. John Mackey, CMO of Pacylex.
“This milestone represents a major step in the development of PCLX-001 as a first-in-class oral cancer therapy” said Pacylex CEO Dr. Michael Weickert. “Our pre-clinical work showed that PCLX-001 at an equivalent dose in animals regressed R/R NHL tumors so it is exciting to see these patients finally receiving this as an investigational therapy” added Dr. Luc Berthiaume, Pacylex CSO and Professor at the University of Alberta.
Twenty-one patients have received PCLX-001 through 6 dose level escalations with no dose limiting toxicities, therefore dose escalation will continue in patients with advanced solid tumors in parallel with the Phase 2a study in patients with R/R NHL. Pacylex anticipates that it will present an update from the Phase 1 dose escalation portion of the study at a scientific conference this year.
Find the full press release here.