Clinical Trials Register

Summary
EudraCT Number:	2015-004314-15
Sponsor's Protocol Code Number:	SP015
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-06-21
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2015-004314-15

A.3

Full title of the trial

A phase I/II, single-arm clinical trial to evaluate the safety and immune activation of the combination of DCVAC/PCa, an active cellular immunotherapy, and ONCOS-102, an immune-priming adenovirus, in men with advanced metastatic castration-resistant prostate cancer.

Jednoramenné klinické hodnocení fáze I/II pro určení bezpečnosti kombinace aktivní buněčné imunoterapie DCVAC/PCa s adenovirem aktivujícím imunitní systém ONCOS-102 a míry aktivace imunitního systému po podání této kombinace u pacientů s pokročilým metastatickým kastračně-rezistentním karcinomem prostaty

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Clinical trial to evaluate the safety and immune activation of DCVAC/PCa and ONCOS-102 in men with metastatic prostate cancer.

Klinické hodnocení pro určení bezpečnosti a aktivace imunitního systému pro kombinaci DCVAC/PCa a ONCOS-102 u pacientů s metastatickou rakovinou prostaty

A.4.1

Sponsor's protocol code number

SP015

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	SOTIO a.s.
B.1.3.4	Country	Czech Republic
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	SOTIO a.s.
B.4.2	Country	Czech Republic
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SOTIO a.s.
B.5.2	Functional name of contact point	Clinical Trial SOTIO
B.5.3	Address:
B.5.3.1	Street Address	Jankovcova 1518/2
B.5.3.2	Town/ city	Prague 7
B.5.3.3	Post code	17000
B.5.3.4	Country	Czech Republic
B.5.6	E-mail	clinicaltrial@sotio.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	DCVAC/PCa
D.3.2	Product code	DCVAC/PCa
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DCVAC/PCa
D.3.9.2	Current sponsor code	DCVAC/PCa
D.3.9.3	Other descriptive name	CELL SUSPENSION CONTAINING DENDRITIC CELLS
D.3.9.4	EV Substance Code	SUB120526
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10000000
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Yes
D.3.11.3.1	Somatic cell therapy medicinal product	Yes
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Oncos-102
D.3.4	Pharmaceutical form	Concentrate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intratumoral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Oncos-102
D.3.9.2	Current sponsor code	Oncos-102
D.3.9.3	Other descriptive name	Ad5/3-D24-GMCSF, CGTG-102
D.3.9.4	EV Substance Code	SUB87690
D.3.10	Strength
D.3.10.1	Concentration unit	billion organisms/ml billion organisms/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Yes
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	Yes
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Yes
D.3.11.3.5.1	CAT classification and reference number	EMA/CAT/644096/2013
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	Yes
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CYCLOPHOSPHAMIDE
D.3.9.1	CAS number	6055-19-2
D.3.9.3	Other descriptive name	CYCLOPHOSPHAMIDE MONOHYDRATE
D.3.9.4	EV Substance Code	SUB16414MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

advanced metastatic castration-resistant prostate cancer

E.1.1.1

Medical condition in easily understood language

metastatic prostate cancer

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10036909
E.1.2	Term	Prostate cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this clinical trial is to evaluate the safety of the combination of DCVAC/PCa with ONCOS-102 primed with cyclophosphamide (CPO) in men with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either hormonal manipulation (eg,abiraerone and enzalutamide) or chemotherapy

E.2.2

Secondary objectives of the trial

• To evaluate time to disease progression demonstrated by prostate-specific antigen (PSA) levels
• To evaluate radiographic progression-free survival by radiographic evidence of disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
• To evaluate overall survival
• To evaluate the objective response rate

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Males 18 years of age and older
2. Histologically or cytologically confirmed adenocarcinoma of the prostate
3. Radiographically documented metastatic disease (presence of skeletal or soft-tissue/visceral/nodal metastases) with evidence of disease according to the following criteria:
- Measurable lymph nodes (short axis ≥ 15 mm) or visceral lesion measurable per RECIST v 1.1 or
- Two or more lesions on bone scan/imaging and with at least one soft tissue or visceral lesion being accessible for intratumoral administration of ONCOS-102 and biopsy.
4. ECOG performance status 0-1
5. PSA ≥2 ng/mL
6. Rising PSA levels after previous treatment failure.
7. Surgically or medically castrate with serum testosterone levels ≤1.7 nmol/L. Patients who have not had bilateral orchiectomy must be maintained on standard dosing of GnRH/LHRH analog therapy at appropriate frequency for the duration of the clinical trial.
8. Laboratory criteria:
a. White blood cell count (WBC) greater than 4,000/mm3 (4.0×109/L)
b. Platelet count of at least 100,000/mm3 (100×109/L)
c. Total bilirubin within normal limits (benign hereditary hyper-bilirubinemias, eg, Gilbert’s syndrome, are permitted)*
d. Serum alanine aminotransferase, aspartate aminotransferase, and creatinine <1.5×ULN *
*If the patient has liver metastases, these parameters might not be applicable and the decision on inclusion of the patient into the study is to be made by the Investigator after discussion with the Sponsor’s Medical Monitor.
9. 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
10. Life expectancy of at least 12 months based on the Investigator’s judgement
11. Signed Informed Consent Form

E.4

Principal exclusion criteria

1. 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
3. Systemic immunosuppressive therapy apart from corticosteroids at a dose of less than 10 mg/day
4. Administration of experimental therapy within the last 4 weeks before start of screening
5. Treatment with immunotherapy within the last 3 months before start of screening
6. Treatment with radiopharmaceutical drugs within 8 weeks before start of screening
7. Patient significant co-morbidities (cardiovascular diseases, eg, unstable angina pectoris, uncontrolled hypertension, myocardial infarction, ventricular arrhythmia, or stroke within a 6-month period before the Baseline visit; congestive heart failure or cardiac arrhythmia not controlled by treatment; active severe infections; uncontrolled metabolic disorders; etc.)
8. Known hypersensitivity or allergic reaction (other than local inflammatory reaction or irritation at injection site) to DCVAC/PCa or its constituents, ie, CryoStor CS10 freeze medium (Biolife Solutions) containing 10% dimethyl sulfoxide
9. Uncontrolled co-morbidities including social conditions which in the Investigator’s opinion would prevent participation in/completion of the clinical trial
10. Patients known to be HIV positive or syphilitic
11. Known active (infectious) hepatitis B and active hepatitis C
12. Known central nervous malignancies such as glioma and brain metastases
13. Receipt of oncolytic virus treatment or vaccination with a live virus within 4 weeks of study start
14. History of organ transplantation
15. Any autoimmune diseases, therapies with monoclonal antibodies, any psychiatric disease, medical history of active TBC and any allogeneic stem cell transplantations in the last 5 years

E.5 End points

E.5.1

Primary end point(s)

Safety profile as measured by adverse events (AEs), serious adverse events (SAEs), laboratory abnormalities, and vital signs

E.5.1.1

Timepoint(s) of evaluation of this end point

after the last visit of the last patient enrolled in the clinical trial.

E.5.2

Secondary end point(s)

• Time to PSA progression demonstrated by a rising PSA value as defined by the Prostate Cancer Working Group 2, ie, 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir, which is confirmed by a second value (also 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir) obtained 3 to 6 weeks later
• Radiographic progression-free survival (per RECIST v 1.1), a composite of:
o radiographic progression of bone lesions
o radiographic progression of soft tissue lesions
o death due to any cause
• Overall survival
• Objective response rate (per RECIST v 1.1)

E.5.2.1

Timepoint(s) of evaluation of this end point

after the last visit of the last patient enrolled in the clinical trial.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last patient last visit

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None. According to normal practice.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-11-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-09-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-01-25

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