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

NCT ID: NCT03514836

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-23
• Study Completion Date: 2021-01-25

Brief 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.

Detailed Description

Study Description:

• All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure.
• ONCOS-102 administration will start within 3 weeks of leukapheresis at Week 5 (35 days since baseline +/- 2 days), and 3 further doses will be administered on a weekly basis
• Cyclophosphamide A priming bolus dose of CPO (300 mg/m2 intravenously) will be given 1-3 days before the first (Week 5) and the fifth (Week 14) of ONCOS-102 administration.
• DCVAC/PCa therapy will start 6 weeks after leukapheresis at Week 8. DCVAC/PCa will be administered subcutaneously in cycles, always on Day 1 (+/- 3 days) of the corresponding cycle.

Conditions

Castration-resistant Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DCVac and ONCOS-102

ONCOS-102 is given intra-tumor up to 4 times, cyclophosphamide is given prior to the first dose of ONCOS-102 and at the fifth week of treatment DCVac is given sc every 21-28 days for up to 10 doses

Group Type: EXPERIMENTAL

DCVac/PCa

Intervention Type: BIOLOGICAL

Oncolytic adenovirus containing immunostimulatory cytokine granulocyte-monocyte colony-stimulating factor (GM-CSF). This is an experimental therapy.

DCVac/Pca consists of activated autologous dendritic cells. This is an experimental therapy.

Cyclophosphamide

Intervention Type: DRUG

immunomodulatory medication given around the ONCOS-102 dosing

Interventions

DCVac/PCa

Oncolytic adenovirus containing immunostimulatory cytokine granulocyte-monocyte colony-stimulating factor (GM-CSF). This is an experimental therapy.

DCVac/Pca consists of activated autologous dendritic cells. This is an experimental therapy.

Intervention Type: BIOLOGICAL

Cyclophosphamide

immunomodulatory medication given around the ONCOS-102 dosing

Intervention Type: DRUG

Other Intervention Names

ONCOS-102

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

SOTIO a.s.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roman Korolkiewicz, MD, PhD

Role: STUDY_DIRECTOR

Sotio as

Locations

Fakultní nemocnice v Motole

Prague, , Czechia

Countries

Czechia

Other Identifiers

SP015

Identifier Type: -

Identifier Source: org_study_id