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    Summary
    EudraCT Number:2022-001191-34
    Sponsor's Protocol Code Number:ASND0029
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-02-27
    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 number2022-001191-34
    A.3Full title of the trial
    IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination with Pembrolizumab, Standard of Care Chemotherapy, or TransCon TLR7/8 Agonist, or in Combination with Pembrolizumab and Standard of Care Chemotherapy, in Adult Participants with Locally Advanced or Metastatic Solid Tumor Malignancies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination with Pembrolizumab and/or Chemotherapy or TransCon TLR7/8 Agonist in Adult Participants with Locally Advanced or Metastatic Solid Tumor Malignancies
    A.3.2Name or abbreviated title of the trial where available
    IL Believe
    A.4.1Sponsor's protocol code numberASND0029
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05081609
    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 SponsorAscendis Pharma Oncology Division A/S
    B.1.3.4CountryDenmark
    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 supportAscendis Pharma Oncology Division A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAscendis Pharma Oncology Division A/S
    B.5.2Functional name of contact pointAssociate Director
    B.5.3 Address:
    B.5.3.1Street Address1000 Page Mill Rd.
    B.5.3.2Town/ cityPalo Alto
    B.5.3.3Post code94304
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650-374-9144
    B.5.6E-mailRTM@ascendispharma.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 nameTransCon IL-2 β/γ
    D.3.2Product code ACP-016
    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 INNTransCon IL-2 β/γ
    D.3.9.2Current sponsor codeACP-016
    D.3.9.4EV Substance CodeSUB271607
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.2.1.2Country 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 nameKEYTRUDA
    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.3.9.3Other descriptive namePembrolizumab
    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.IMP: 3
    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 nameTransCon TLR7/8 Agonist
    D.3.2Product code ACP-017
    D.3.4Pharmaceutical form Suspension 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 INNTransCon TLR7/8 Agonist
    D.3.9.2Current sponsor codeACP-017
    D.3.9.4EV Substance CodeSUB224151
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    locally advanced or metastatic solid tumor malignancies, platinum resistant ovarian cancer, post-anti-pd-1 melanoma, second line or later cervical cancer, neoadjuvant melanoma and neoadjuvant non-small cell lung cancer
    E.1.1.1Medical condition in easily understood language
    Locally Advanced or Metastatic Solid Tumor Malignancies
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.1
    E.1.2Level PT
    E.1.2Classification code 10085681
    E.1.2Term Carbohydrate antigen 242
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    − The main objective of Part 1 and 2 was to evaluate the safety and tolerability, and define the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TransCon IL-2 β/γ alone or in combination with pembrolizumab
    − The main objective of Part 3 is to evaluate the safety and tolerability of TransCon IL-2 β/γ at RP2D as monotherapy and in combination with pembrolizumab, standard of care (SOC) chemotherapy, or TransCon TLR7/8 Agonist, or in combination with pembrolizumab and SOC chemotherapy
    E.2.2Secondary objectives of the trial
    - To evaluate the antitumor activity of TransCon IL-2 β/γ alone or in combination with pembrolizumab, SOC chemotherapy, or TransCon TLR7/8 Agonist, or in combination with pembrolizumab and SOC chemotherapy
    - To characterize the plasma pharmacokinetics (PK) of TransCon IL-2 β/γ and Free IL-2 β/γ alone or in combination with pembrolizumab,
    SOC chemotherapy, or TransCon TLR7/8 Agonist, or in combination with pembrolizumab and SOC chemotherapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participants must be at least 18 years of age at the time of signing the informed consent;
    -Capable of giving signed informed consent;
    -Archival or newly obtained formalin-fixed tissue of tumor specimen:
    -Part 3, Cohort 3, 4 and 5: A tumor biopsy sample must be provided at baseline unless deemed unfeasible. A fresh biopsy is preferred, but archival tissue is also acceptable.
    -Part 3, Cohorts 6a-c and 7: archival tissue or newly obtained formalin-fixed tumor tissue;
    -Demonstrated adequate organ function at screening drawn within 28 days prior to C1D1;
    -Life expectancy >12 weeks as determined by the Investigator;
    -For women of childbearing potential: agreement to remain abstinent.
    -Part 3 ECOG: 0 or 1
    Cohort 3,
    -Histologic or cytologic documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Carcinosarcoma, sarcoma, mucinous ovarian cancer, or low-grade serous histologies are excluded;
    -Must have platinum-resistant ovarian cancer;
    -participants must be appropriate candidates for treatment with single agent paclitaxel, docetaxel, or pemetrexed at study entry based on treating investigator’s clinical assessment;
    -At least 1 measurable target lesion as per RECIST 1:1.
    Cohort 4:
    -Histologically or cytologically confirmed diagnosis of unresectable (stage III) or metastatic (stage IV) cutaneous melanoma who have progressed on anti-PD-1 therapy or had recurrence <6 months after adjuvant anti-PD-1 therapy;
    -At least 2 target lesions of measurable disease per RECIST 1.1, at least 1 lesion that is safely accessible for intratumoral injection and is also ≥15 mm in the longest diameter;
    -Participants may not have liver metastases;
    Cohort 5:
    - Histologically or cytologically confirmed diagnosis of extra-pelvic metastatic or recurrent cervical cancer with squamous cell, adenocarcinoma or adenosquamous histology who are not candidates for curative therapy.
    - Have received at least 1, but no more than 2 prior systemic treatment regimens for recurrent or metastatic cervical cancer.
    - Participants who have undergone treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody must have evidence of disease progression.
    - At least 2 target lesions of measurable disease per RECIST 1.1, at least 1 lesion that is safely accessible for intratumoral injection and is also ≥15 mm in the longest diameter.
    - Participants may not have liver metastases
    Cohort 6a-c:
    -Histologically or cytologically confirmed diagnosis of resectable cutaneous melanoma;
    -Complete surgical resection must be deemed achievable;
    -No prior radiotherapy or systemic anticancer therapy for melanoma;
    -At least one lesion that is safely accessible for intratumoral injection and is also ≥15 mm in the longest diameter
    Cohort 7:
    -Histologically or cytologically confirmed NSCLC without EGFR-activating mutations, ALK or ROS1 rearrangements and with completely resectable disease, according to AJCC 8th edition;
    -Complete surgical resection must be deemed achievable;
    -No prior radiotherapy or systemic anticancer therapy for NSCLC;
    -Participants must have adequate cardiopulmonary function;
    -Evaluable disease with at least 1 measurable target lesion per RECIST 1.1 criteria
    Other protocol-defined inclusion criteria may apply.
    E.4Principal exclusion criteria
    -Symptomatic central nervous system metastases;
    -Active autoimmune diseases,
    -Any uncontrolled bacterial, fungal, viral, or other infection;
    -Significant cardiac disease;
    -A marked clinically significant baseline prolongation of QT/QTc interval, using Fridericia’s QT correction formula
    -Positive for HIV or has known active hepatitis B or C infection;
    -Known hypersensitivity to any study treatment;
    - Participants who have been previously treated with IL-2 or IL-2 variants (all participants) or TLR agonist, excluding topical agents for unrelated disease (Part 3, Cohorts 4, 5 and 6 ONLY);
    - Systemic immunosuppressive treatment with the exception for participants on corticosteroid taper (for example, for chronic obstructive pulmonary disease exacerbation);
    - Vaccination with live, attenuated vaccines within 4 weeks of C1D1.
    -Women who are breastfeeding or have a positive serum pregnancy test during screening
    Exclusion Criteria Specific to Part 3 ONLY
    -Other active malignancies within the last 2 years.
    Other protocol-defined exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    Treatment emergent and treatment related adverse events, serious adverse events (SAEs), adverse events leading to treatment discontinuation, deaths.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through study completion, expected average of 2 years
    E.5.2Secondary end point(s)
    Part 3- cohorts 3,4,5:
    -Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), duration of response (DoR), and time to response
    (TTR) per independent central review (ICR)
    - ORR by RECIST 1.1, DoR, and TTR per investigator assessment
    - Progression-free survival (PFS) by RECIST 1.1 per ICR
    - PFS by RECIST 1.1 per investigator assessment
    - Overall Survival (OS);
    Part 3, cohorts 6a-c, and Cohort 7
    - ORR prior to surgery by RECIST 1.1 per ICR
    - ORR prior to surgery by RECIST 1.1 per investigator assessment
    - Pathologic complete response (pCR) per central assessment for pathology review
    - Major pathologic response (MPR) per central assessment for pathology review
    - pCR per local assessment for pathology review
    - MPR per local assessment for pathology review
    - Event-free survival (EFS) by RECIST 1.1 per ICR
    - EFS by RECIST 1.1 per investigator assessment
    - OS

    -TransCon IL-2 β/γ and free IL-2 β/γ PK parameters, alone or in combination with pembrolizumab, SOC chemotherapy, or TransCon TLR7/8 Agonist, or in combination with pembrolizumab and SOC chemotherapy
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Overall Response Rate-Time Frame: Average of 2 years
    2.Pathologic Complete Response-Time Frame: 15 weeks
    3.Major Pathologic Response-Time Frame: 15 weeks
    4.Duration of Response-Time Frame: Average of 2 years
    5.Time to Response-Time Frame: Expected up to 1 year from first dose
    6.Progression Free Survival (PFS)-Time Frame: Average of 2 years
    7.Event free survival (EFS) by RECIST 1.1-Time Frame: 2 years
    8.Overall Survival (OS) -Time Frame: Average of 2 years
    9.PK Characterization (Cmax) -Time Frame: Average of 2 years
    10.PK Characterization (Tmax) -Time Frame: Average of 2 years
    11.PK Characterization (AUClast) -Time Frame: Average of 2 years
    12.PK Characterization (AUC0-t) -Time Frame: Average of 2 years
    13.PK Characterization (t1/2) -Time Frame: Average of 2 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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    -Tolerability
    -Immunogenicity
    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 Yes
    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 trial7
    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 EEA30
    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
    Singapore
    Switzerland
    Taiwan
    Australia
    Canada
    Korea, Republic of
    United Kingdom
    United States
    Belgium
    France
    Italy
    Poland
    Spain
    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
    Last Visit Last Patient
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 172
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 115
    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 143
    F.4.2.2In the whole clinical trial 287
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    After study discontinuation, the subjects will be treated by their physician according to their medical condition and standard treatments in the country concerned
    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 Decision2023-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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