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    Clinical Trial Results:
    A non-controlled, single arm, open label, Phase II study of intravenous and intratumoral administration of ParvOryx in patients with metastatic, inoperable pancreatic cancer

    Summary
    EudraCT number
    		 2015-001119-11
    Trial protocol
    		 DE  
    Global end of trial date
    28 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions
    Summary report(s)
    		 ParvOryxSynopsis_sign

    Trial information

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    Trial identification
    Sponsor protocol code
    ParvOryx02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02653313
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Oryx GmbH und Co. KG
    Sponsor organisation address
    Marktplatz 1, Baldham, Germany, 85598
    Public contact
    Dr. Bernhard Huber (CEO), Oryx GmbH und Co. KG, +49 8106213110, info@oryx-medicine.com
    Scientific contact
    Dr. Ottheinz Krebs (COO), Oryx GmbH und Co. KG, +49 8106213110, info@oryx-medicine.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • Primary objectives: To investigate the safety and tolerability of the ParvOryx as well as the associated virus distribution, shedding and elimination • Secondary objectives: To provide proof of concept for ParvOryx in the treatment of pancreatic cancer assessed by laboratory and clinical characteristics
    Protection of trial subjects
    Sequential enrolment Sequential dose escalation Safety data were reviewed by a data safety monitoring board (DSMB) Hospitalisation during and after application of IMP
    Background therapy
    		 In accordance with the European ‘Guidance on investigational medicinal products (IMPs) and non investigational medicinal product (NIMPs)’, gemcitabine and nab-paclitaxel were defined as non-investigational medicinal products.
    Evidence for comparator
    		 Not applicable (no comparator)
    Actual start date of recruitment
    17 Feb 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    6
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients were recruited in Germany; 7 patients were treated between 17th February 2016 (first screening examination) and 21st February 2018 (last study visit)

    Pre-assignment
    Screening details
    		 Screening phase: Not more than 14 days before the first administration of ParvOryx. Eligible were Patients with stage IV pancreatic ductal adenocarcinoma and at least one hepatic metastasis.

    Pre-assignment period milestones
    Number of subjects started
    		 7
    Number of subjects completed
    		 7

    Period 1
    Period 1 title
    Screening
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dose level 1
    Arm description
    		 Administration of IMP at the total dose of 1E09 pfu. The total dose was applied by the following scheme: Intravenous: 1 x 1E8 pfu (2-hour infusion) per day over 4 days, intratumorally: 6 x 1E8 pfu (slow infusion).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ParvOryx
    Investigational medicinal product code
    Other name
    Parvovirus H1 in Visipaque/Ringer solution
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratumoral use, Intravenous use
    Dosage and administration details
    Dose level 1: – Intravenous: 1 x 1E8 pfu (2-hour infusion) per day over 4 days – Intratumoral: 6 x 1E8 pfu (slow infusion) – Total dose: 1 x 1E9 pfu

    Arm title
    		 Dose level 2
    Arm description
    		 Administration of IMP at the total dose 5E09 pfu. The total dose was applied by the following scheme: Intravenous: 5 E08 pfu (2-hour infusion) per day over 4 days, and an intratumoral slow infusion of 3 E09 pfu.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ParvOryx
    Investigational medicinal product code
    ParvOryx
    Other name
    Parvovirus H-1 in Visipaque/Ringer solution
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratumoral use, Intravenous use
    Dosage and administration details
    Dose level 2: – Intravenous: 5 E08 pfu (2-hour infusion) per day over 4 days – Intratumoral: 3 E09 pfu (slow infusion) – Total dose: 5 E09 pfu

    Arm title
    		 Dose level 3
    Arm description
    		 Administration of IMP at a total dose of 1E10 pfu. The total dose was applied by the following scheme: 1 x 1E9 pfu intravenous (2-hour infusion) per day over 4 days and Intratumoral: 6 x 1E9 pfu (administered in one slow infusion).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ParvOryx
    Investigational medicinal product code
    ParvOryx
    Other name
    Parvovirus H-1 in Visipaque/Ringer solution
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratumoral use, Intravenous use
    Dosage and administration details
    Dose level 3: – Intravenous: 1 x 1E9 pfu (2-hour infusion) per day over 4 days – Intratumoral: 6 x 1E9 pfu (slow infusion) – Total dose: 1 x 1E10 pfu

    Number of subjects in period 1
    		Dose level 1 Dose level 2 Dose level 3
    Started
    1
    3
    3
    Completed
    1
    3
    3
    Period 2
    Period 2 title
    Treatment & Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dose Level 1
    Arm description
    		 Administration of IMP at the total dose of 1E09 pfu. The total dose was applied by the following scheme: Intravenous: 1 x 1E8 pfu (2-hour infusion) per day over 4 days, intratumorally: 6 x 1E8 pfu (slow infusion).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ParvOryx
    Investigational medicinal product code
    ParvOryx
    Other name
    Parvovirus H-1 in Visipaque/Ringer solution
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratumoral use, Intravenous use
    Dosage and administration details
    Dose level 1: – Intravenous: 1 x 1E8 pfu (2-hour infusion) per day over 4 days – Intratumoral: 6 x 1E8 pfu (slow infusion) – Total dose: 1 x 1E9 pfu

    Arm title
    		 Dose Level 2
    Arm description
    		 Administration of IMP at the total dose 5E09 pfu. The total dose was applied by the following scheme: Intravenous: 5E08 pfu (2-hour infusion) per day over 4 days, and an intratumoral slow infusion of 3E09 pfu.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ParvOryx
    Investigational medicinal product code
    Parvoryx
    Other name
    Parvovirus H-1 in Visipaque/Ringer solution
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intratumoral use, Intravenous use
    Dosage and administration details
    Dose level 2: – Intravenous: 5 x 1E8 pfu (2-hour infusion) per day over 4 days – Intratumoral: 3 x 1E9 pfu (slow infusion) – Total dose: 5 x 1E9 pfu

    Arm title
    		 Dose Level 3
    Arm description
    		 Administration of IMP at a total dose of 1E10 pfu. The total dose was applied by the following scheme: 1 x 1E9 pfu intravenous (2-hour infusion) per day over 4 days and Intratumoral: 6 x 1E9 pfu (administered in one slow infusion).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ParvOryx
    Investigational medicinal product code
    ParvOryx
    Other name
    Parvovirus H-1 in Visipaque/Ringer solution
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratumoral use, Intravenous use
    Dosage and administration details
    Dose level 3: – Intravenous: 1 x 1E9 pfu (2-hour infusion) per day over 4 days – Intratumoral: 6 x 1E9 pfu (slow infusion) – Total dose: 1 x 1E10 pfu

    Number of subjects in period 2
    		Dose Level 1 Dose Level 2 Dose Level 3
    Started
    1
    3
    3
    Completed
    1
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Screening
    Reporting group description
    		 All patients enrolled are reported regarding baseline characteristica

    Reporting group values
    		 Screening Total
    Number of subjects
    		 7 7
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Age (full analysis set)
    Units: years
        arithmetic mean (standard deviation)
    		 55.1 ± 10.6 -
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 4 4
    Subject analysis sets

    Subject analysis set title
    Full analysis set/Saftey set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set (FAS): Consists of those subjects who were included in the trial and received the study medication at least once. The term "Intention-to-treat analysis” (ITT analysis) is used for an analysis applying the ITT principle to all subjects of the FAS. This means that alle subjects are analysed as if they had been treated as specified in the study protocol. In this study, the safety set is identical to the FAS.

    Subject analysis set title
    Dose level 1
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Administration of IMP at the total dose of 1E09 pfu. The total dose was applied by the following scheme: Intravenous: 1 x 1E8 pfu (2-hour infusion) per day over 4 days, intratumorally: 6 x 1E8 pfu (slow infusion).

    Subject analysis set title
    Dose level 2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Administration of IMP at the total dose 5E09 pfu. The total dose was applied by the following scheme: Intravenous: 5 E08 pfu (2-hour infusion) per day over 4 days, and an intratumoral slow infusion of 3 E09 pfu.

    Subject analysis set title
    Dose Level 3
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Administration of IMP at a total dose of 1E10 pfu. The total dose was applied by the following scheme: 1 x 1E9 pfu intravenous (2-hour infusion) per day over 4 days and Intratumoral: 6 x 1E9 pfu (administered in one slow infusion).

    Subject analysis sets values
    		 Full analysis set/Saftey set Dose level 1 Dose level 2 Dose Level 3
    Number of subjects
    7
    1
    3
    3
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    6
    1
    3
    2
        From 65-84 years
    1
    0
    0
    1
        85 years and over
    0
    0
    0
    0
    Age continuous
    Age (full analysis set)
    Units: years
        arithmetic mean (standard deviation)
    55.1 ± 10.6
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    3
        Male
    4

    End points

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    End points reporting groups
    Reporting group title
    Dose level 1
    Reporting group description
    		 Administration of IMP at the total dose of 1E09 pfu. The total dose was applied by the following scheme: Intravenous: 1 x 1E8 pfu (2-hour infusion) per day over 4 days, intratumorally: 6 x 1E8 pfu (slow infusion).

    Reporting group title
    Dose level 2
    Reporting group description
    		 Administration of IMP at the total dose 5E09 pfu. The total dose was applied by the following scheme: Intravenous: 5 E08 pfu (2-hour infusion) per day over 4 days, and an intratumoral slow infusion of 3 E09 pfu.

    Reporting group title
    Dose level 3
    Reporting group description
    		 Administration of IMP at a total dose of 1E10 pfu. The total dose was applied by the following scheme: 1 x 1E9 pfu intravenous (2-hour infusion) per day over 4 days and Intratumoral: 6 x 1E9 pfu (administered in one slow infusion).
    Reporting group title
    Dose Level 1
    Reporting group description
    		 Administration of IMP at the total dose of 1E09 pfu. The total dose was applied by the following scheme: Intravenous: 1 x 1E8 pfu (2-hour infusion) per day over 4 days, intratumorally: 6 x 1E8 pfu (slow infusion).

    Reporting group title
    Dose Level 2
    Reporting group description
    		 Administration of IMP at the total dose 5E09 pfu. The total dose was applied by the following scheme: Intravenous: 5E08 pfu (2-hour infusion) per day over 4 days, and an intratumoral slow infusion of 3E09 pfu.

    Reporting group title
    Dose Level 3
    Reporting group description
    		 Administration of IMP at a total dose of 1E10 pfu. The total dose was applied by the following scheme: 1 x 1E9 pfu intravenous (2-hour infusion) per day over 4 days and Intratumoral: 6 x 1E9 pfu (administered in one slow infusion).

    Subject analysis set title
    Full analysis set/Saftey set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set (FAS): Consists of those subjects who were included in the trial and received the study medication at least once. The term "Intention-to-treat analysis” (ITT analysis) is used for an analysis applying the ITT principle to all subjects of the FAS. This means that alle subjects are analysed as if they had been treated as specified in the study protocol. In this study, the safety set is identical to the FAS.

    Subject analysis set title
    Dose level 1
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Administration of IMP at the total dose of 1E09 pfu. The total dose was applied by the following scheme: Intravenous: 1 x 1E8 pfu (2-hour infusion) per day over 4 days, intratumorally: 6 x 1E8 pfu (slow infusion).

    Subject analysis set title
    Dose level 2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Administration of IMP at the total dose 5E09 pfu. The total dose was applied by the following scheme: Intravenous: 5 E08 pfu (2-hour infusion) per day over 4 days, and an intratumoral slow infusion of 3 E09 pfu.

    Subject analysis set title
    Dose Level 3
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Administration of IMP at a total dose of 1E10 pfu. The total dose was applied by the following scheme: 1 x 1E9 pfu intravenous (2-hour infusion) per day over 4 days and Intratumoral: 6 x 1E9 pfu (administered in one slow infusion).

    Primary: Safety and tolerability of ParvOryx

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    End point title
    		 Safety and tolerability of ParvOryx [1]
    End point description
    Treatment with ParvOryx is considered as safe and well-tolerated if none of the following events occurs: • Elevation of ALAT, ASAT, alkaline phosphatase, or bilirubin > 3 times of the baseline value up to Day 28, • CRP > 3 times of the baseline value up to Day 28, • Neutrophiles < 1.0 x 1E09/L or > 12.0 x 1E09/L up to Day 28, • Hemoglobin < 7.5 g/L up to Day 28, • Thrombocytes < 50 x 1E09/L • INR> 2.5 or aPTT >50 sec. up to Day 28, • Neurological symptoms with no other explanation than administration of ParvOryx (e.g. brain metastasis) up to Day 28, • Thromboembolic event(s), myocardial infarction or stroke • Deteriorations in medical parameters, which were classified as at least ‘possibly’ related to the IMP and required countermeasures to avert conditions fulfilling at least one of the ‘seriousness’-criteria, throughout the trial. • SAE(s) classified as at least ‘possibly’ related to the IMP throughout the trial • medical necessity to interrupt or terminate treatment
    End point type
    Primary
    End point timeframe
    during treatment phase and follow-up
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics only
    End point values
    		 Dose Level 1 Dose Level 2 Dose Level 3 Full analysis set/Saftey set
    Number of subjects analysed
    1
    3
    3
    7
    Units: number of patients who tolerated IMP
    1
    2
    2
    5
    No statistical analyses for this end point

    Secondary: Median Progression-Free Survival

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    End point title
    		 Median Progression-Free Survival
    End point description
    End point type
    Secondary
    End point timeframe
    The complete trial
    End point values
    		 Full analysis set/Saftey set
    Number of subjects analysed
    7
    Units: days
    72
    No statistical analyses for this end point

    Secondary: Median Overall Survival

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    End point title
    		 Median Overall Survival
    End point description
    End point type
    Secondary
    End point timeframe
    troughout the trial
    End point values
    		 Full analysis set/Saftey set
    Number of subjects analysed
    7
    Units: days
    176
    No statistical analyses for this end point

    Secondary: Adverse Events

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    End point title
    		 Adverse Events
    End point description
    End point type
    Secondary
    End point timeframe
    Thoughout the trial
    End point values
    		 Dose Level 1 Dose Level 2 Dose Level 3 Full analysis set/Saftey set
    Number of subjects analysed
    1
    3
    3
    7
    Units: Events
    15
    49
    31
    95
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    throughout the trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Dose Level 1
    Reporting group description
    		 -

    Reporting group title
    Dose Level 2
    Reporting group description
    		 -

    Reporting group title
    Dose Level 3
    Reporting group description
    		 -

    Serious adverse events
    		 Dose Level 1 Dose Level 2 Dose Level 3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
         number of deaths (all causes)
    1
    3
    2
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Hypercalcaemia
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial infection
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dose Level 1 Dose Level 2 Dose Level 3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 1 (100.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
         occurrences all number
    0
    2
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Sep 2015
    This amendment (approved by the PEI not needed; by the EC on 29th September 2015) concerned additional requirement made by the PEI. This amendment led to protocol version 5.
    24 Feb 2016
    This amendment (approved by the EC on 24th February 2016 and by the PEI on 26th February 2016) concerned the implementation of MRI as the basis for assessment of clinical response (additional assessment on the days of intratumoral administration and on Day 28). In addition, an Information sheet for patients' relatives was provided for approval to the EC. This amendment led to protocol version 6.
    15 Jul 2016
    This amendment (approved by the PEI on 15th July 2016 and by the EC on 21st June 2016) concerned exclusion criterion no. 3: “peritoneal carcinosis” was augmented with “clinically apparent ascites”, and some other, formal, changes were made. This amendment led to protocol version 7.
    25 Oct 2016
    This amendment (approved by the PEI on 3rd November 2016 and by the EC on 25th October 2016) concerned the annual up-date of the IB only. This amendment affected the IB only.
    14 Dec 2016
    This amendment (approved by the PEI not needed; by the EC on 14th December 2016) concerned a change of personnel; a second deputy of the principal investigator changed (formerly Dr. Athanasios Mavratzas, then Dr. Nicolas Hohmann) and information about prolongation of trial duration. (See Appendix 16.1.1.7.) This was an administrative amendment and did not require a new protocol version.
    03 Jan 2017
    This amendment (approved by the PEI on 20th January 2017 and by the EC on 3rd January 2107) allowed the parallel inclusion of patients nos. 4 and 5 and of patients nos. 6 and 7. This amendment led to protocol version 8.
    26 Sep 2017
    This amendment (approved by the PEI on 10th October 2017 and by the EC on 26th September 2017) concerned the annual up-date of the IB only. This amendment affected the IB only.
    10 Apr 2018
    This amendment (approved by the PEI on 23rd April 2018 and by the EC on 10th April 2018) introduced the replacement of all patients who did not receive the complete course of study treatment. This amendment led to protocol version 9.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    not applicable
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