Pidnarulex and Talazoparib in Patients With Metastatic Castration Resistant Prostate Cancer
Status:
Not yet recruiting
Trial end date:
2025-12-30
Target enrollment:
Participant gender:
Summary
This is phase I, open label, multicentre, dose-escalation study where both doses of
talazoparib and pidnarulex will be escalated to define the maximum tolerated dose (MTD) and
recommended phase 2 dose (RP2D) for the combination. It is possible that either 1 or 2 RP2D
of the combination will be defined at the end of the study. Patients with disease that is
deemed to be amendable to repeated tumour biopsies will be invited to undergo optional paired
biopsies: at baseline and Cycle 1 Day 9 + 3 days and at the time of progression. Pidnarulex
will be given as an IV infusion on days 1 and 8 of a 28 day cycle and talazoparib will be
taken once daily continuously. Disease status will be assessed at regular intervals by CT
scans, radionuclide bone scans, and PSA. Throughout the study, safety and tolerability will
be assessed and established procedures for management of toxicities will be applied