IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer
brief summary
Dose escalation study to evaluate the safety, tolerability and anti-tumor activity of single agent IMU-935 in patients with progressive, metastatic castration resistant prostate cancer (mCRPC).
detailed description
This is an open-label, non-randomized Phase 1 dose escalation, followed by dose expansion, study to define the safety, tolerability, biomarker change and anti-tumor activity of IMU-935 in patients with mCRPC. Throughout the study, safety, anti-tumor activity, biomarkers and IMU-935 plasma concentrations will be evaluated at regular intervals as per schedule of assessments. Disease progression will be assessed as per standard medical practice.
The dose escalation and expansion parts of the study will have the same treatment duration with similarly structured treatment cycles.
The study will consist of the following periods:
* Screening Period: Approximately 28 days * Treatment Phase:
Main treatment over 3 cycles of 28 days each, extended treatment as long as patient benefits
official title
Dose Escalation Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Single Agent IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer