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    Summary
    EudraCT Number:2020-003802-30
    Sponsor's Protocol Code Number:OMO-103-01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-11-29
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-003802-30
    A.3Full title of the trial
    A Phase 1/2 Study to evaluate the Safety, Pharmacokinetics, and Anti-Tumour Activity of the Myc Inhibitor OMO-103 administered intravenously in Patients with Advanced Tumours.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A two-part study to investigate the safety, pharmacokinetics and effects of a new medication called OMO-103 as a treatment for Advanced Tumours.
    A.4.1Sponsor's protocol code numberOMO-103-01
    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 SponsorPeptomyc S.L.
    B.1.3.4CountrySpain
    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 supportPeptomyc S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPEPTOMYC S.L.
    B.5.2Functional name of contact pointDr. Manuela Niewel
    B.5.3 Address:
    B.5.3.1Street AddressCellex Center, C/Natzaret
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code115-117
    B.5.3.4CountrySpain
    B.5.4Telephone number+34670327414
    B.5.6E-mailmniewel@peptomyc.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 nameOmomyc
    D.3.2Product code OMO-103
    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 INNOmomyc
    D.3.9.2Current sponsor codeOMO-103
    D.3.9.3Other descriptive nameOMO-103
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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
    Solid tumours
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung 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 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 21.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal 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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    Part 1 (Dose Escalation)
    To evaluate the safety and tolerability of OMO-103 in adult patients with advanced solid tumours.

    Part 2 (Dose Expansion)
    To assess the preliminary anti-tumour activity of OMO-103 monotherapy as measured by PFS according to standard criteria (Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 [Eisenhauer 2009] for advanced tumours and RECIL for lymphomas [Younes et al 2017]).
    E.2.2Secondary objectives of the trial
    Part 1 (Dose Escalation)
    • To establish and confirm the RP2D and dosing regimen of OMO-103 for further development
    • To characterise the PK of OMO-103
    • To evaluate preliminary anti-tumour activity in the dose escalation part as measured by PFS, DCR, ORR, TTP, TTR and DOR according to standard criteria (RECIST v1.1 [Eisenhauer 2009] for advanced tumours)
    • To assess the development of human ADA to OMO-103

    Part 2 (Dose Expansion)
    • To confirm the RP2D and dosing regimen of OMO-103 for further development
    • To evaluate a dose-response relationship in PDAC patients
    • To assess the type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory abnormalities
    • To characterise the PK of OMO-103
    • To assess other efficacy parameters in patients with advanced tumours including DCR, ORR, TTP, TTR, DOR and OS by RECIST v1.1/RECIL
    • To assess the development of human ADA to OMO-103
    • To evaluate Quality of Life (QoL) in patients with advanced tumours
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part 1 (Dose Escalation):
    1. Histologically or cytologically proven advanced solid tumour for which there is no curative therapy and has progressed on standard-of-care (SOC) treatment or is intolerant to or has no available SOC or SOC unacceptable.

    Part 2 (Dose Expansion):
    Histologically or cytologically proven advanced NSCLC whose tumours are KRAS-mutated and where the disease has progressed after patients have received one line of nationally available licensed standard chemotherapy and immunotherapy regimen either in combination or sequentially or for which available/further licensed treatment options are not suitable, patients with a KRASG12C mutation should have progressed on a KRAS-inhibitor (e.g., Sotorasib/Adagrasib), advanced PDAC where the disease has progressed after having received at least one line of prior nationally available licensed systemic treatment for advanced disease or for which available/further licensed treatment options are not suitable, and advanced DHL where the disease has progressed after at least two lines of prior nationally available licensed standard regimen or for which available/further licensed treatment options are not suitable.

    Parts 1 and 2:
    2. Patients must have measurable disease as per RECIL/RECIST v1.1 criteria and documented by PET-CT (DHL patients) or CT/MRI (all other tumour entities). NOTE: Lesions to be used as measurable disease for the purpose of response assessment must either:
    a. not reside in a field that has been subjected to prior radiotherapy, or
    b. have demonstrated clear evidence of radiographic progression since the completion of prior radiotherapy and prior to study enrolment.
    3. Tumour biopsy (either from the primary tumour or from metastases) during Screening and during Treatment has to be obtained from the patients. Discussion needed with Sponsor if considered not feasible. In Part 1 only from the 3rd dose level onwards.
    4. For each patient undergoing pre- and on-treatment biopsies, the identified lesion to be biopsied should not have been previously irradiated and should not be the only lesion being utilised as a measurable-disease target lesion for objective response assessment. Patients must have tumour lesions that can be accessed for biopsy with acceptable clinical risk in the judgement of the Investigator.
    5. Documented progression on or following the last line of therapy.
    6. Male or female, 18 years of age or older.
    7. ECOG performance status up to 1.
    8. Life expectancy of ≥12 weeks.
    9. Resolution of all acute, reversible toxic effects of prior therapy or surgical procedure to Grade ≤1 (except alopecia and peripheral neuropathy to Grade ≤2).
    10. Adequate organ function as defined by the following criteria:
    Haematological:
    a. Neutrophils ≥1,000/μL
    b. Platelets ≥100,000/μL; For DHL patients only: ≥50,000/μL
    c. Haemoglobin ≥9 g/dL
    Renal:
    a. Creatinine Clearance (calculated via Cockcroft-Gault Equation) ≥40 mL/min.
    Hepatic:
    a. Serum total bilirubin ≤1.5 ULN or
    b. Direct bilirubin ≤ULN for patients with total bilirubin >1.5 ULN
    c. AST/SGOT and ALT/SGPT ≤2.5 ULN or ≤5 ULN if liver metastases
    Coagulation:
    a. INR ≤1.5
    b. aPTT ≤1.5 ULN
    Chemistry:
    a. Albumin >25 g/L
    11. If not postmenopausal or surgically sterile, female patients must be willing to practice at least one of the following highly effective methods of birth control (defined as having a low failure rate) for at least a menstrual cycle before and for 4 months after last study drug administration:
    a. True abstinence, when this is in line with the preferred and usual lifestyle of the patient, from sexual intercourse with a member of the opposite sex;
    b. Sexual intercourse with vasectomised male;
    c. Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal) for at least 3 consecutive months prior to investigational product administration (when not clinically contraindicated as in breast, ovarian and endometrial cancers);
    d. Use of an intrauterine contraceptive device.
    12. Male patients and their sexual partners must use an appropriate contraceptive from Screening for 4 months after last study drug administration, including:
    a. True abstinence
    b. Male sterilisation
    c. Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal) and condom
    d. Intrauterine contraceptive device and condom.
    13. Informed consent document signed and dated by the patient, indicating that he/she has been informed of all the pertinent aspects of the trial prior to any study-related procedure not part of normal medical care.
    14. Willingness and ability to comply with the protocol for the duration of the study, including scheduled visits, treatment plan, laboratory tests, and other trial procedures.
    E.4Principal exclusion criteria
    Parts 1 and 2:
    1. Experimental anti-cancer therapy within 4 weeks prior to study entry.
    2. Radiation therapy within 4 weeks prior to study entry. Localised palliative radiotherapy to non-target lesions is allowed.
    3. Previous or concurrent malignancy that could affect compliance with the protocol or interpretation of results. Patients curatively treated more than 2 years prior to enrolment, and patients with adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ are eligible.
    4. Non-malignant systemic disease including cerebrovascular accident (CVA), unstable angina pectoris, unstable atrial fibrillation, unstable cardiac arrhythmia, myocardial infarction in the last 6 months, NYHA Class III or IV heart failure.
    5. Patients with active uncontrolled infection or known to be serologically positive for human immunodeficiency virus (HIV), hepatitis B (except after vaccination) or hepatitis C infection. Investigators may test as per their discretion.
    6. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
    7. Pregnant or nursing.
    8. Patients with symptomatic or unstable central nervous system (CNS) primary tumour or metastases and/or carcinomatous meningitis. Patients with documented treated CNS metastases stable for at least 4 weeks may be enrolled at the discretion of the Investigator.
    9. Live vaccine within 4 weeks of administration of study drug.
    10. Current participation in another trial.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: Dose Escalation:
    • Number of patients with a DLT;
    • Number of patients with ≥1 AE;
    • Number of patients discontinuing study treatment due to AEs.

    Part 2: Dose Expansion
    • PFS based on RECIST v1.1 and RECIL as evaluated by the site investigator and independent reader.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1: Dose Escalation:
    • Evaluated during cycle 1
    • AEs are evaluated ongoing bases
    • Number of patients discontinuing are evaluated on an ongoing basis

    Part 2: Dose Expansion
    • PFS will be evaluated on an ongoing basis
    E.5.2Secondary end point(s)
    The secondary endpoints of the study are the PK profile, as well as tumour response.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The PK profile and tumour responses will be evaluated on an ongoing basis.
    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 Yes
    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 Yes
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 90
    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)
    According to investigators standard therapy
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-21
    P. End of Trial
    P.End of Trial StatusCompleted
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