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    Summary
    EudraCT Number:2022-000176-19
    Sponsor's Protocol Code Number:IP-IIO-622
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-06-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2022-000176-19
    A.3Full title of the trial
    Intratumoral injection of IP-001 following thermal ablation in patients with advanced solid tumors. A multicenter Phase 1b/2a trial in colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Injection of IP-001 into thermally ablated solid tumors.
    A.4.1Sponsor's protocol code numberIP-IIO-622
    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 SponsorImmunophotonics Inc.
    B.1.3.4CountryUnited States
    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 supportImmunophotonics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmunophotonics Inc.
    B.5.2Functional name of contact pointVP, Regulatory and Clinical Affairs
    B.5.3 Address:
    B.5.3.1Street Address4340 Duncan Ave. BioGenerator Labs, Suite 212
    B.5.3.2Town/ citySt Louis
    B.5.3.3Post codeMO 63110
    B.5.3.4CountryUnited States
    B.5.4Telephone number314-266-2625
    B.5.6E-mailtrials@immunophotonics.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 nameIP-001
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratumoral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.2Current sponsor codeIP-001
    D.3.9.3Other descriptive nameN-Dihydrogalactochitosan
    D.3.9.4EV Substance CodeSUB273674
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number9.0 to 11.0
    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.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
    Colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma patients
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma patients
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10029514
    E.1.2Term Non-small cell lung cancer NOS
    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 10075333
    E.1.2Term Soft tissue sarcoma
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10010029
    E.1.2Term Colorectal cancer NOS
    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
    The primary objective is to determine safety and tolerability of 1.0% IP-001 for Injection administered intratumorally following thermal ablation of a solid tumor.
    E.2.2Secondary objectives of the trial
    The secondary objective is to determine anti-tumor activity of 1.0% IP-001 for Injection administered intratumorally following thermal ablation of a solid tumor.
    The exploratory objectives of the trial are translational research to:
    • Determine the presence and nature of the immune response elicited by 1.0% IP-001 for Injection administered intratumorally following thermal ablation of a solid tumor
    • Determine the formation of anti-drug antibodies (ADA) by 1.0% IP-001 for Injection administered intratumorally following thermal ablation of a solid tumor
    • Determine the correlation between a tumor market and response to 1.0% IP-001 for Injection administered intratumorally following thermal ablation of a solid tumor
    • Determine the pharmacokinetics of 1.0% IP-001 for Injection
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed and dated informed consent from patient in accordance with local regulatory and/or national laws and ICH/GCP regulations before registration and before any study specific activity is performed.
    2.Patients with either histologically or cytologically confirmed Stage 3 or Stage 4 CRC, NSCLC, or STS who
    a.have failed, are ineligible, or become intolerant to at least first line (but no more than 4 lines) of systemic therapy,
    b.have a life expectancy of > 6 months,
    c.only have lesions with the longest diameter of ≤ 5 cm, and
    d.would benefit from RFA alone as part of routine care or have a treatment
    plan that includes RFA alone.
    3.Presence of at least one non-bone tumor lesion that is ablation-accessible, with a minimum size of 1.0 cm and located such that it can be treated without risk of skin necrosis or serious damage to other adjacent vital and healthy tissue.
    4.Measurable or evaluable disease, determined with the most suitable imaging method, either computed tomography (CT) or magnetic resonance imaging (MRI), according to RECIST 1.1.
    5.Age ≥ 18 years.
    6.ECOG performance status 0-1.
    7.Bone marrow function: neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 90 g/L.
    8.Adequate hematological function defined by white blood cell count ≥ 2.5 × 109/L with absolute neutrophil count ≥ 1.5 × 109/L, hemoglobin ≥ 9 g/dL, and coagulation (partial thromboplastin time [PPT] = 25.0-33.0 seconds, activated partial thromboplastin time [aPTT] depends on local methodology and reference standards, and international normalized ratio [INR] = 0.8-1.2) (transfusions allowed on study if received at least 14 days prior to assessing hematological samples).
    9.Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and aspartate transaminase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 × ULN for all patients, or for patients with documented metastatic disease to the liver and AST and ALT levels ≤ 5 × ULN. Patients with documented Gilbert disease are allowed if total bilirubin is less than 3 × ULN.
    10.Adequate renal function defined by an estimated creatinine clearance ≥ 50 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).
    11.Women with childbearing potential are using highly effective contraception (achieve a failure rate of less than 1% per year in accordance with the national guidance), are not pregnant or lactating and agree not to become pregnant during trial treatment and for an additional 187 days after the last dose of investigational drug. Women of childbearing potential must have a negative serum human chorionic gonadotropin pregnancy test before inclusion.
    12.Men agree not to donate sperm or to father a child during trial treatment and until 97 days after the last dose of investigational drug.
    13.In France, the patient must be affiliated to a social security system, and currently benefit from the corresponding rights and cover, in accordance with French Public Health Code.
    E.4Principal exclusion criteria
    1.Known allergic reaction to shellfish, crabs, crustaceans, or any trial components, used in trial treatment.
    2.Malignant primary brain tumors or evidence of brain metastases or leptomeningeal disease as ascertained by clinical examination and brain imaging (MRI or CT).
    3.Patients who have received chemotherapy, radiotherapy, immunotherapy, or concurrent or recent treatment with any other investigational agents within 21 days (7 days for single fraction of palliative radiotherapy, 42 days for nitrosoureas or mitomycin C) prior to treatment.
    4.Patients who have not recovered to common terminology criteria for adverse events (CTCAE) Grade ≤ 1 from all side effects of prior therapies except for residual toxicities, such as alopecia or Grade 2 neuropathy, which do not pose an ongoing medical risk.
    5.Patients with a history of malignancy, with the exception of non-melanoma skin cancers and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, prostate, or breast, or has undergone potentially curative therapy with no evidence of disease recurrence for at least 3 years prior to the first trial treatment and no additional therapy is required or anticipated to be required during the trial period. Other exceptions may be considered with Sponsor consultation.
    6.Concomitant treatment with systemic corticosteroids (daily dose not to exceed 10 mg prednisolone or equivalent) or other immunosuppressive therapy (e.g., methotrexate).
    7.Oral anti-coagulation with vitamin K antagonists (e.g., phenprocoumon, warfarin) and heparin, including therapeutically dosed low molecular weight heparins, which cannot be stopped 24 hours prior to trial treatment (low-dose aspirin allowed) and bleeding diathesis.
    8.Severe or uncontrolled cardiovascular disease (congestive heart failure New York Heart Association classification III or IV), unstable angina pectoris, history of myocardial infarction within the last 6 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation, uncontrolled hypertension.
    9.Known history of human immunodeficiency virus or active chronic Hepatitis C or Hepatitis B Viral infection or any uncontrolled active systemic infection requiring intravenous antimicrobial treatment.
    10.Serious autoimmune disease (e.g., systemic lupus erythematosus) which is judged to reduce an anti-tumor immune response.
    11.Any other serious underlying medical (e.g., patients who have a non-controlled infection that requires systemic therapy), psychological, familial or geographical condition, which in the judgment of the Investigator may limit compliance with the planned staging, treatment and follow-up, or place the patient at high risk from treatment-related complications.
    12.Patient not eligible for general endotracheal anesthesia, if necessary, for thermal ablation treatment.
    13.Persons deprived of liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a health or social institution for purposes other than research, persons who is the subject of a legal protection measure (tutelage, guardianship, safeguard of justice), and persons ≥ 18 years old unable to express consent and who is not subject to a legal protection measure.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be assessed by adverse events (AEs), vital sign measurements, physical examination findings, Eastern Cooperative Oncology Group (ECOG) performance status, pulmonary function, clinical laboratory assessments, and electrocardiogram (ECG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From start of trial treatment until 90 days after the last trial treatment.
    E.5.2Secondary end point(s)
    • Disease control according to Response Evaluation Criteria in Solid Tumors for immune-based treatments (iRECIST) (iDC)
    • Disease control according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (DC)
    • Objective response according to iRECIST (iOR)
    • Duration of response according to iRECIST (iDOR)
    • Progression-free survival according to iRECIST (iPFS)
    • Objective response according to RECIST 1.1 (OR)
    • Duration of response according to RECIST 1.1 (DOR)
    • Progression-free survival according to RECIST 1.1 (PFS)
    • Time to response according to iRECIST 1.1 (iTTR)
    • Time to response according to RECIST 1.1 (TTR)
    • Disease-free survival (DFS)
    • Overall survival (OS)
    • OR of the injected lesions according to RECIST 1.1
    • OR of the non-injected lesions according to RECIST 1.1
    • iOR of the injected lesions according to iRECIST
    • iOR of the non-injected lesions according to iRECIST
    E.5.2.1Timepoint(s) of evaluation of this end point
    For 12 weeks.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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
    Phase 1b
    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 Yes
    E.8.1.7.1Other trial design description
    Multicenter study with 3 Cohorts
    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 trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Switzerland
    United Kingdom
    France
    Germany
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 20
    F.4.2.2In the whole clinical trial 44
    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)
    All patients to be followed up to 6 months after the final treatment.
    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 Decision2023-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2025-01-08
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