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    Summary
    EudraCT Number:2021-006804-34
    Sponsor's Protocol Code Number:CYP003
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-06
    Trial 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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-006804-34
    A.3Full title of the trial
    A Phase 1b/2a, Open-Label, Multi-Center Study of CyPep-1 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety of CyPep-1 in Patients With Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), Melanoma, or Triple-Negative Breast Cancer (TNBC) (CATALYST)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and efficacy of CyPep-1 in combination with Pembrolizumab for the treatment of advanced or metastatic cancers.
    A.3.2Name or abbreviated title of the trial where available
    CATALYST
    A.4.1Sponsor's protocol code numberCYP003
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCytovation ASA
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCytovation ASA
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace UK
    B.5.2Functional name of contact pointDirector, Clinical Trial Management
    B.5.3 Address:
    B.5.3.1Street AddressVintners' Place, 68 Upper Thames Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC4V 3BJ
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailC.Synaeve@Medpace.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCyPep-1
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratumoral use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCyPep-1
    D.3.9.3Other descriptive nameCyPep-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Keytruda
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePembrolizumab
    D.3.2Product code MK-3475
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    Advanced or metastatic:
    -Head and Neck Squamous Cell Carcinoma (HNSCC);
    -Melanoma;
    -Triple-Negative Breast Cancer (TNBC);
    E.1.1.1Medical condition in easily understood language
    Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10075566
    E.1.2Term Triple negative breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025650
    E.1.2Term Malignant melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1b
    -Confirm the recommended CyPep-1 dose (20 mg Q2W) when administered by IT injection in combination with pembrolizumab

    Phase 2a
    -Assess the anti-tumor activity of CyPep-1 administered by IT injection in combination with pembrolizumab
    E.2.2Secondary objectives of the trial
    Phase 1b
    -Evaluate the PK of CyPep-1 in combination with pembrolizumab

    Phase 2a
    -Expand evaluation of efficacy CyPep-1 + pembrolizumab
    -Evaluate the safety and tolerability of CyPep-1 in combination with pembrolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion Criteria
    1. 18 years of age or older on the day of signing informed consent
    2. Provide written informed consent and are able to comply with study procedures and assessments
    3. Have measurable disease per RECIST v1.1 as assessed by the local site Investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
    4. Have at least 1 non-ulcerated, measurable, and accessible lesion for IT injection with a maximum diameter of 5 cm
    5. Are able to provide tissue from a core or excisional biopsy at screening or have an acceptable stored tumor sample available that was collected within 90 days prior to screening
    6. Have an ECOG performance status of 0 or 1
    7. Have a life expectancy ≥3 months, as determined by the Investigator
    8. Female patients of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before screening), post-menopausal, defined as spontaneous amenorrhea for at least 2 years, or with follicle-stimulating hormone in the post-menopausal range at screening
    9. Female patients of childbearing potential must have a negative serum pregnancy test at screening and agree to use a highly effective method for contraception from the time of signing the ICF until at least 120 days after the last administration of study treatment. Highly effective methods of contraception are birth control methods with a failure rate of <1% per year when used consistently and correctly, including the following:
    a. Combined estrogen- and progestin-containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally; progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant; intrauterine devices; and intrauterine hormone-releasing systems
    b. Female sterilization (surgical bilateral oophorectomy with/without hysterectomy, total hysterectomy, bilateral tubal occlusion/ligation) at least 26 weeks prior to first study treatment
    c. Sterilization of male partner (at least 6 months prior to first study treatment dose)
    d. Complete sexual abstinence. Periodic abstinence and withdrawal are not acceptable. Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient.
    10. Male patients able to father children, must agree to use 2 acceptable methods of contraception throughout the study. Sperm donation is not recommended from the time of signing the ICF until at least 120 days after the last administration of study treatment
    11. Have adequate organ function
    Inclusion Criteria for Arm A
    Patients who meet all of the general Inclusion Criteria and the following additional criteria will be eligible for inclusion in Arm A:
    1. Have histologically confirmed diagnosis of HNSCC (including nasopharyngeal squamous cell carcinoma)
    2. Have advanced or metastatic HNSCC incurable by standard of care therapies
    3. Have recurrent or metastatic HNSCC that has progressed on or failed both platinum-based chemotherapy AND an ICI (given either sequentially or concurrently)
    Inclusion Criteria for Arm B
    Patients who meet all of the general Inclusion Criteria and the following additional criteria will be eligible for inclusion in Arm B:
    1. Have histologically confirmed diagnosis of malignant melanoma
    2. Do not have uveal melanoma
    3. Have advanced or metastatic melanoma incurable by standard of care therapies;
    4. Have received a combination of a BRAF inhibitor and a MEK inhibitor if diagnosed with a BRAF mutated melanoma and if clinically indicated;
    5. Have failed or progressed on or after treatment with a checkpoint inhibitor administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies
    Inclusion Criteria for Arm C
    Patients who meet all of the general Inclusion Criteria and the following additional criteria will be eligible for inclusion in Arm C:
    1. Have histologically confirmed diagnosis of TNBC as per ASCO/CAP guidelines
    2. Have advanced or metastatic TNBC incurable by standard of care therapies
    3. Have received sacituzumab govitecan chemotherapeutic treatment if clinically indicated
    4. Have failed or progressed on or after treatment with a checkpoint inhibitor administered either as monotherapy or in combination with other therapies (if ICI eligible based on programmed cell death ligand 1 (PD-L1) status) OR have received prior systemic therapy with either an anthracycline- or taxane containing regimen (if ICI non-eligible based on PD-L1 status)
    E.4Principal exclusion criteria
    1. Have only non-palpable cutaneous infiltrations
    2. Have had anti-cancer therapy within 4 weeks prior to the first dose of study treatment (2 weeks for palliative radiotherapy)
    3. Have participated in a clinical trial and received an investigational therapy within 30 days prior to the first dose of study treatment
    4. Have received or will receive a live or live attenuated vaccine within 30 days prior to the first dose of study treatment
    5. Have tested positive for severe acute respiratory SARS-CoV-2 infection within 14 days prior to the Screening Visit
    6. Have had a major surgical procedure within 14 days prior to the first dose of study treatment
    7. Are expected to require a systemic or localized anti-neoplastic therapy during participation in this study, excluding localized palliative radiotherapy to tumors not selected for evaluation of treatment response
    8. Are pregnant or breastfeeding
    9. Have clinical evidence of a secondary malignancy actively progressing or requiring active treatment other than curative therapies for early stage (carcinoma in situ or Stage 1) carcinomas or non-melanoma skin cancer
    10. Have had any autoimmune disease requiring immunosuppressive therapy within 2 years prior to the first dose of study treatment
    11. Have a condition requiring continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of study treatment. Inhaled, intranasal, or topical (only on areas outside the injected lesion[s]) and physiological replacement doses of up to 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
    12. Have abnormal or clinically significant coagulation parameters as determined by the Investigator (eg, PT, INR, aPTT) unless patients are on anti-coagulants in which case it must be within appropriate clinical levels
    13. Have a significant history or clinical manifestation of any allergic disorders and/or Quincke’s edema (as determined by the Investigator) capable of significantly altering the absorption of drugs, of constituting a risk when taking CyPep-1 or pembrolizumab, or of interfering with the interpretation of the data
    14. Have a known hypersensitivity to any component of CyPep-1 or pembrolizumab
    15. Have a history of adverse reactions from treatment with ICIs, including pembrolizumab, which resulted in discontinuation of ICI or pembrolizumab or has ongoing pembrolizumab-related toxicity event(s) as per treatment-limiting toxicity definitions, except patients with ongoing endocrine disorders that are managed with replacement therapy (ie, hypothyroidism related to prior pembrolizumab treatment)
    16. Have an active infection requiring systemic therapy
    17. Have a known history of Hepatitis B or known active Hepatitis C virus infection
    18. Have had radiotherapy within 2 weeks prior to the first dose of study treatment, are in recovery from radiation toxicity, or have had radiation pneumonitis
    19. Have a history of non-infectious pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
    20. Have had a prior allogeneic tissue/solid organ transplant, stem cell, or bone marrow transplant
    21. Have active HIV. Patients are eligible when on stable anti-retroviral therapy (no change in medication or dose) for at least 4 weeks prior to screening, have confirmed virologic suppression with HIV RNA less than 50 copies/mL or the lower limit of quantification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening, and have a cluster of differentiation 4+ T cell count >350 cells/mm3 at screening. HIV-infected patients with a history of Kaposi sarcoma and/or Multicentric Castleman Disease will be excluded
    22. Have 4 or more sites involved, including the primary cancer
    23. Have a CNS metastasis that is symptomatic, progressing, or that requires current therapy
    24. Have a QTcF >480 ms at screening, history of long or short QT syndrome, Brugada syndrome, QTc prolongation, or Torsade de Pointes, with the exception of patients with controlled atrial fibrillation, pacemaker, or bundle branch block as the QTc will be prolonged due to the widened QRS
    25. Are an adult under legal protection, are vulnerable, or lack the capacity to give informed consent, such as: Persons deprived of liberty by a judicial or administrative decision; Adult persons subject to a legal protection measure (under supervision/under guardianship); Persons under a judicial protection measure
    26. Have a history of or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient’s participation for the full duration of the study, or make participation in the study not in the best interest of the patient, in the opinion of the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1b
    • Incidence, frequency, and seriousness of TEAEs;
    • Incidence of DLTs; and
    •Changes from baseline in vital signs, body weight, 12 lead ECG parameters, and laboratory assessments.

    Phase 2a
    ORR based on radiological assessment according to RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    • TEAEs: Continuously throughout trial
    • The dose-limiting toxicity (DLT) period for the Phase 1b portion of the study will be 6 weeks
    • The Objective Response Rate (ORR) will be based on the number of patients achieving a partial response (PR) or CR based on
    RECIST v1.1 and iRECIST
    E.5.2Secondary end point(s)
    Phase 1b
    • Plasma concentration-time profile of CyPep-1
    Phase 2a
    • ORR according to iRECIST;
    • DCR according to iRECIST and RECIST v1.1;
    • DoR according to iRECIST and RECIST v1.1;
    • PFS according to iRECIST and RECIST v1.1; and
    • OS for up to 26 months from Cycle 1 Visit 1.
    • Incidence, frequency, and seriousness of TEAEs; and
    • Changes from baseline in vital signs, body weight, 12 lead ECG parameters, and laboratory assessments.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Continuously throughout trial
    • Plasma samples will be collected pre dose and 15 minutes, 30 minutes, 1 hour, 2 hours, and 4 hours post-dose on Cycle 1 Day 15.
    • Progression Free Survival (PFS) (percentage of patients alive and progression-free) at 6, 12, 18, and 24 months after the first treatment with CyPep 1 + pembrolizumab
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    To confirm the recommended CyPep-1 dose (20 mg Q2W) when administered by IT injection
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    France
    Italy
    Netherlands
    Spain
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of the study (“study completion”) is defined as the date of the last protocol-specified visit/assessment for the last patient in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 90
    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)
    Patients who are alive at the end of the study after completing all 18 cycles of treatment and the Safety Follow-up Visit may be entered into a separate long-term follow-up study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-30
    P. End of Trial
    P.End of Trial StatusOngoing
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