NCT05124795

IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Immunic AG · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Metastatic Castration Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	IMU-935	IMU-935 capsules

Timeline

• Start date: 2021-12-09
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2021-11-18
• Last updated: 2024-01-17

Locations

1 site across 1 country: United Kingdom