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    Summary
    EudraCT Number:2020-004175-41
    Sponsor's Protocol Code Number:NIT-109
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-04-23
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-004175-41
    A.3Full title of the trial
    A Multicenter, Open-label, Phase 2 Study of NT-I7 in Combination with Nivolumab in Subjects Relapsed/Refractory Gastric or Gastro-Esophageal Junction or Esophageal Adenocarcinoma who Progressed on or Intolerant to 2 or more Prior Lines of Systemic Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Open-label, Phase 2 Study of NT-I7 in Combination with Nivolumab in Subjects with Advanced or Metastatic Stomach, Esophageal Cancers who Progressed on or Were Intolerant to 2 or More Previous Therapies
    A.3.2Name or abbreviated title of the trial where available
    NT-I7 in Combination with Nivolumab in Advanced Gastric, GEJ, or EAC
    A.4.1Sponsor's protocol code numberNIT-109
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04594811
    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 SponsorNeoImmuneTech, 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 supportNeoImmuneTech, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeoImmuneTech, Inc.
    B.5.2Functional name of contact pointClinical Division
    B.5.3 Address:
    B.5.3.1Street Address2400 Research Blvd. Suite 250
    B.5.3.2Town/ cityRockville
    B.5.3.3Post code20850
    B.5.3.4CountryUnited States
    B.5.6E-mailNIT109@neoimmunetech.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 nameNT-I7
    D.3.2Product code NT-I7
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEfineptakin alfa
    D.3.9.2Current sponsor codeNT-I7
    D.3.9.3Other descriptive namerhIL-7-hyFc
    D.3.9.4EV Substance CodeSUB213575
    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.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 Opdivo
    D.2.1.1.2Name of the Marketing Authorisation holderBristol Myers Squibb EEIG
    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 nameNivolumab
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form 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 INNnivolumab
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Relapsed/refractory gastric or gastro-esophageal junction (GEJ) or esophageal adenocarcinoma (EAC) progressed on or intolerant to 2 or more prior lines of systemic therapy
    E.1.1.1Medical condition in easily understood language
    Cancer in the stomach and/or esophagus, called gastric, gastro-esophageal junction (GEJ) or esophageal adenocarcinoma (EAC).
    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 LLT
    E.1.2Classification code 10058526
    E.1.2Term Oesophageal adenocarcinoma metastatic
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10082464
    E.1.2Term Advanced gastric carcinoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084873
    E.1.2Term Gastrooesophageal junction cancer metastatic
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Dose escalation: To evaluate the safety and tolerability of NT-I7 in combination with nivolumab, including estimation of the MTD and/or the recommended Phase 2 dose (RP2D) in subjects with advanced or metastatic solid tumours.
    Phase 2: To assess the antitumor activity of NT-I7 in combination with nivolumab in subjects with Relapsed/Refractory gastric or GEJ or EAC after 2 or more prior lines of systemic therapy, based on:
    Objective response rate (ORR) per Independent Review Committee (IRC) assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
    E.2.2Secondary objectives of the trial
    To assess ORR per IRC assessment using iRECIST.
    To further assess the antitumor activity of NT-I7 in combination with nivolumab in the treated subjects, based on Duration of Response (DoR), Disease Control Rate (DCR), Progression-Free Survival (PFS) per IRC assessment, and Overall survival (OS).
    To evaluate the immunogenicity of NT-I7 administered in combination with nivolumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria
    1. Subjects enrolling in the dose escalation phase must have histologically or cytologically confirmed locally advanced or metastatic solid tumor and can be either CPI-pretreated or CPI-naive.
    2. For the Phase 2, 1) subjects must have histologically or cytologically confirmed locally advanced or metastatic carcinoma of gastric or GEJ or EAC and 2) have progressed on 2 or more prior lines of standard therapy including chemotherapy, immunotherapy and targeted therapy. Note: Confirmation radiographic progression on prior therapy is required at least 4 weeks from the initial disease progression. Screening scans can be used as the confirmation of progression. Progression following target therapy, or other approved or investigational therapies is allowed. Note: GEJ adenocarcinomas are defined as tumors that have their center within 5 cm proximal and distal of the anatomical cardia, as described in the Siewert classification system (Siewert et al, 2000)
    3. Have at least one measurable lesion according to RECIST 1.1.
    4. Subjects enrolling in the dose escalation phase may have biopsiable disease. It is optional for subjects to provide a) pre-treatment tumor tissue sample and b) on-treatment tumor biopsy.
    5. In the Phase 2 at least 20 subjects are required to provide tumor tissue sample. These subjects must have biopsiable disease (i.e. at least 1 tumor lesion that is accessible and feasible for biopsy) as determined by the investigator. These 20 subjects must agree to provide a) pre-treatment tumor tissue sample and b) on-treatment tumor biopsy. Fresh tumor biopsies are preferred.
    6. Female subjects are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks; if a female subject is of childbearing potential, she must agree to remain abstinent (refrain from heterosexual intercourse) or to follow instructions for one highly effective method of contraception for the duration of study treatment and for 5 months after the last dose of study treatment.
    7. Non-sterile male subjects who are sexually active with female partners of childbearing potential must agree to remain abstinent
    (refrain from heterosexual intercourse) or to follow instructions for one highly effective method of contraception for the duration of study treatment and for 3 months after the last dose of study treatment.
    E.4Principal exclusion criteria
    Key Exclusion Criteria
    1. Pregnant, or breastfeeding or expecting to conceive or father children within the study duration from screening through 5 months (for female subjects) or 7 months (for male subjects) after the last dose of study treatment.
    2. Receiving chemotherapy or any anti-cancer therapy with half-life < 1 week within 4 weeks or 5 half-lives, whichever is shorter, prior to first dose of study treatment.
    3. Has received prior radiotherapy within 2 weeks of start of study treatment.
    4. Has received treatment with complementary medications (ex, herbal supplements, or traditional Chinese medications) to treat the disease under study within 2 weeks prior to the first dose of study treatment.
    5. Subjects are eligible if CNS metastases are asymptomatic and do not require immediate treatment or have been treated and subjects have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).
    6. Subjects who have not recovered from AE due to agents administered > 4 weeks earlier (i.e., have residual toxicities > Grade 1).
    7. Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
    8. History of severe hypersensitivity reactions to monoclonal antibodies (mAbs) or intravenous immunoglobulin preparation. Any history of anaphylaxis.
    9. Subject who have spinal cord compression not definitively treated with surgery and/or radiation.
    10. Subject who have an active, known or suspected auto-immune disease
    11. Have active and clinically relevant bacterial, fungal, viral or tuberculosis infection
    12. Clinically significant cardiac disease.
    13. Subjects who have received treatment with systemic immunosuppressive medications within 1 week prior to the first dose of study treatment.
    14. History of allergy or intolerance (unacceptable AEs) to study drug components or polysorbate-80-containing injection. Note: Polysorbate 80 is a buffer used to make NT-I7.
    15. History of non-infectious pneumonitis.
    16. Has received a live/attenuated vaccine within 4 weeks prior to the first dose of study drug. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed.
    17. Has had an allogenic tissue/solid organ transplant or bone marrow transplant.
    18. Receiving monoclonal antibodies (mAbs), and/or mAb-derived therapies within 4 weeks prior to first dose of study treatment.
    19. Subjects who were intolerable and discontinued from prior immune checkpoint inhibitors.
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) assessed by the Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors
    (RECIST) version 1.1 is the primary endpoint for Phase 2. ORR is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR), per RECIST 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 2 years.
    E.5.2Secondary end point(s)
    Duration of response (DoR), disease control rate (DCR), progression-free survival (PFS) and Incidence of anti-drug antibodies (ADA) to NT-I7 during the study relative to baseline are the secondary endpoints for Phase 2.
    DOR is defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST 1.1.
    DCR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD), per RECIST 1.1.
    PFS is defined as the time from the first study treatment to the first occurrence of disease progression or death of any cause, whichever occurs first, per RECIST 1.1.
    OS is defined as the time from first study treatment to death from any cause.
    ORR defined as the percentage of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR) , per iRECIST as determined by the IRC
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 3.5 years.
    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 No
    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
    To evaluate the immunogenicity of NT-I7 administered in combination with nivolumab;
    To make a preliminary assessment of biomarkers that might act as pharmacodynamic indicators of antitumor activity of NT-I7 in combination with nivolumab in the treated subjects;
    To make a preliminary assessment of biomarkers that might act as predictors of antitumor activity of NT-I7 in combination with nivolumab in the treated subjects.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    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 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 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
    Poland
    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
    LVLS
    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 months5
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 68
    F.1.3Elderly (>=65 years) No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 68
    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)
    Subjects who continue to receive clinical benefit after 24 months from the date of first dose, may continue to receive the treatment on this study, via a rollover study requiring approval by the responsible Health Authority (HA) and ethics committee, or through another mechanism at the discretion of the Sponsor. The Sponsor reserves the right to terminate access to study treatment due to any of the resons described in the protocol (section 7.8).
    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 Decision2021-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-05-26
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