A Phase I/II, Safety Clinical Trial of DCVAC/PCa and ONCOS-102 in Men With Metastatic Castration-resistant Prostate Cancer

• Status: Terminated
• Trial end date: 2021-01-25
• Target enrollment: 0
• Participant gender: Male

Summary

This clinical trial is to evaluate the safety of the combination of DCVAC/PCa with ONCOS-102 in men with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either hormones (e.g. abiraterone and enzalutamide) or chemotherapy.

Male patients with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either All patients must have at least one readily accessible soft tissue/nodal tumor lesion (for intra-tumoral application of ONCOS-102 and biopsy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SOTIO a.s.
• Treatments: Cyclophosphamide

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate

• Radiographically documented metastatic disease with evidence of disease progression Laboratory parameters per protocol

• Surgically or medically castrate

• Patients who have progressed following:

• a. at least initial therapy (chemotherapy or treatment with a hormonal agent known to impact survival such as abiraterone and enzalutamide); or

• b. one first-line chemotherapy regimen and one additional hormonal agent known to impact survival such as abiraterone and enzalutamide; or

• c. failure of two lines of chemotherapy; or

• d. failure of pre-chemotherapy abiraterone or enzalutamide and subsequent chemotherapy

Exclusion Criteria:

• Patients with neuroendocrine or small cell cancer of the prostate 2. History of other malignant disease (with the exception of the primary prostate cancer and non-melanoma skin tumors) in the past 5 years Pre-defined co-morbidities

• Administration of experimental therapy within the last 4 weeks before start of screening

• Treatment with immunotherapy within the last 3 months before start of screening

• Treatment with radiopharmaceutical drugs within 8 weeks before start of screening

• Receipt of oncolytic virus treatment or vaccination with a live virus within 4 weeks of study start

• History of organ transplantation