Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05124795
Study type Interventional
Source Immunic AG
Contact
Status Terminated
Phase Phase 1
Start date December 9, 2021
Completion date May 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT02495974 - European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Completed NCT03641560 - A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy Phase 4
Terminated NCT02441517 - A Study of Enzalutamide Re-treatment in Metastatic Castration-resistant Prostate Cancer After Docetaxel and/or Cabazitaxel Treatment Phase 4
Active, not recruiting NCT03454750 - Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC) Phase 2
Completed NCT03776968 - A Study Evaluating HC-1119 Single-Dose Pharmacokinetics and Effect of Food on Its Pharmacokinetics Phase 1
Completed NCT02471469 - Personalizing Enzalutamide Therapy by Understanding the Relation Between Tumor mRNAs, miRNAs and Treatment Response
Terminated NCT03177187 - Combination Study of AZD5069 and Enzalutamide. Phase 1/Phase 2
Terminated NCT03531827 - Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment Phase 2
Active, not recruiting NCT02566772 - Study of TAS3681 in Metastatic Castration Resistant Prostate Cancer Phase 1
Completed NCT03829436 - TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers Phase 1
Active, not recruiting NCT05241613 - A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer Phase 1
Recruiting NCT05369000 - Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer Phase 1/Phase 2
Active, not recruiting NCT02975934 - A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency Phase 3
Active, not recruiting NCT04869488 - A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer Phase 2
Completed NCT00428220 - A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study. N/A
Completed NCT04056754 - Study of Abiraterone Acetate in Subjects With Metastatic Castration Resistant Prostate Cancer Phase 3
Completed NCT03658447 - PRINCE (PSMA-lutetium Radionuclide Therapy and ImmuNotherapy in Prostate CancEr) Phase 1/Phase 2
Terminated NCT03042312 - Lutetium-177 (Lu177) Prostate-Specific Antigen (PSMA)-Directed EndoRadiotherapy Phase 2
Completed NCT02991911 - A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer Phase 1
Completed NCT02426333 - Optimizing Abiraterone Therapy