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

• ClinicalTrials.gov Identifier: NCT03514836
• Recruitment Status: Recruiting
• First Posted: May 2, 2018
• Last Update Posted: June 12, 2018
• Sponsor: Sotio a.s.
• Information provided by (Responsible Party): Sotio a.s.

Tracking Information

• First Submitted Date: April 11, 2018
• First Posted Date: May 2, 2018
• Last Update Posted Date: June 12, 2018
• Actual Study Start Date: May 23, 2018
• Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 1, 2018)

Progression Free Survival [ Time Frame: 96 months ]

PFS measured by modifications to the RECIST 1.1. PFS is defined as the time from the first dose of SoC therapy administered to tumor progression or death from any cause.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 1, 2018)

• Overall Survival [ Time Frame: 96 months ]
  Defined as the time from Baseline visit to the date of death for any cause
• Safety [ Time Frame: 96 months ]
  Reports of adverse events, serious adverse events, lab abnormalities utilizing NCI CTCAE v.4.033
• Time to Progression-PSA [ Time Frame: 96 months ]
  demonstrated by rising PSA as defined by the Prostate Cancer Workging Group2
• Radiographic Progression- free survival [ Time Frame: 96 months ]
  composite assessment of progression of bone lesions, soft-tissue lesions or death due to any cause

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase I/II, Safety Clinical Trial of DCVAC/PCa and ONCOS-102 in Men With Metastatic Castration-resistant Prostate Cancer
• Official Title: A Phase I/II, Clinical Trial to Evaluate the Safety and Immune Activation of the Combination of DCVAC/PCa, and ONCOS-102, in Men With Advanced Metastatic Castration-resistant Prostate Cancer.

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.

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Open label combination treatment

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Castration-resistant Prostate Cancer

Intervention

• Biological: DCVac/PCa
  Oncolytic adenovirus containing immunostimulatory cytokine granulocyte-monocyte colony-stimulating factor (GM-CSF). This is an experimental therapy
  Other Name: ONCOS-102
• Drug: Cyclophosphamide
  immunomodulatory medication given around the ONCOS-102 dosing

Study Arms

Experimental: 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

Interventions:

• Biological: DCVac/PCa
• Drug: Cyclophosphamide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 1, 2018): 15
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2021
• Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Prostate Cancer

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Richard Kapsa; (+420) 2241 74448; kapsa@sotio.com

• Listed Location Countries: Czechia

Administrative Information

• NCT Number: NCT03514836
• Other Study ID Numbers: SP015
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Sotio a.s.
• Study Sponsor: Sotio a.s.
• Collaborators: Not Provided

Investigators

• Study Director: Inna Krasnopolskaya, MD; Sotio as

• PRS Account: Sotio a.s.
• Verification Date: May 2018