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    Summary
    EudraCT Number:2022-002432-31
    Sponsor's Protocol Code Number:MP0533-CP101
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-10-11
    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 number2022-002432-31
    A.3Full title of the trial
    A phase 1/2a, first-in-human, open-label, multicenter, dose escalation study of MP0533 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of MP0533 in patients with blood cancer.
    A.4.1Sponsor's protocol code numberMP0533-CP101
    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 SponsorMolecular Partners AG
    B.1.3.4CountrySwitzerland
    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 supportMolecular Partners AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMolecular Partners AG
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street AddressWagistrasse 14
    B.5.3.2Town/ cityZurich-Schlieren
    B.5.3.3Post code8952
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4144 755 7700
    B.5.6E-mailNicolas.Leupin@molecularpartners.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 nameMP0533
    D.3.2Product code MP0533
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNTBC
    D.3.9.2Current sponsor codeMP0533
    D.3.9.3Other descriptive nameDARP in targeting three different tumor associated antigens in AML and MDS
    D.3.9.4EV Substance CodeSUB295334
    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 (R/R) acute myeloid leukemia (AML) or
    myelodysplastic syndrome (MDS)
    E.1.1.1Medical condition in easily understood language
    Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
    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 10000880
    E.1.2Term Acute myeloid leukaemia
    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 10028533
    E.1.2Term Myelodysplastic syndrome
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigating MP0533 as monotherapy in patients with R/R AML
    and MDS/AML is to:
    • Determine the safety and tolerability
    • Define the recommended phase 2 dose regimen (RP2D-R) and/or the maximum tolerated dose-regimen (MTD-R) (phase 1 only)
    • Evaluate the preliminary anti-leukemic activity (primary for phase 2a, secondary for phase 1)
    E.2.2Secondary objectives of the trial
    Investigating MP0533 as monotherapy in patients with R/R AML
    and MDS/AML is to:
    • Further evaluate the preliminary anti-leukemic activity
    • Characterize the pharmacokinetics (PK)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has signed and dated written informed consent prior to performing any study procedure, including screening
    2. Diagnosis of AML or MDS/AML according to the ELN recommendation 2022 (Appendix 12.1 of the protocol), refractory or relapsed to pretreatment with hypomethylating agents (HMA) (with or without venetoclax), induction chemotherapy or allogeneic hematopoietic cell transplantation (HCT)
    3. Age ≥18 years old on the day of signing informed consent
    4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2 (see Appendix 12.2 of the protocol)
    5. Anticipated life expectancy ≥ 12 weeks by investigator judgement
    6. Adequate renal and hepatic function:
    a. Creatinine clearance > 40 mL/min on the basis of Cockcroft-Gault glomerular filtration rate estimation, unless considered AML- or MDS-related
    b. Serum bilirubin ≤ 2.5 x upper limit of normal (ULN), unless considered AML- or MDS-related or due to Gilbert’s syndrome
    c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN, unless considered AML- or MDS-related
    7. Is using highly effective contraception, for females of childbearing potential (FCBP) and for men
    E.4Principal exclusion criteria
    1. Allogeneic HCT within the last 3 months
    2. Active GvHD requiring immune-suppressive therapy (other than prednisone (or equivalent) ≤ 10mg/d)
    3. Use of immunosuppressive drugs (other than prednisone (or equivalent) ≤10mg/d) in the past 4 weeks
    4. Symptoms of leukostasis (prior hydroxyurea allowed)
    5. Clinical signs of AML in the central nervous system
    6. Major surgery within 28 days prior to start of study medication
    7. Other malignancy requiring active therapy, but adjuvant endocrine therapy is allowed
    8. Any active infection requiring the use of parenteral antimicrobial agents or that is grade >2
    9. Treatment with agents targeting CD33, CD123 or CD70 within 4 weeks prior to start of trial medication
    10. Left ventricular ejection fraction of < 50% on echocardiographic exam at screening
    11. History or evidence of clinically significant cardiovascular disease
    12. Pulmonary disease with clinically relevant hypoxia
    13. Known Human Immunodeficiency Virus (HIV)-infected patients who are healthy and have a low risk of Acquired Immunodeficiency Syndrome (AIDS)-related outcomes may be eligible (see protocol)
    14. Active hepatitis B (chronic or acute; HBV)
    15. Active hepatitis C (HCV) infection
    16. Any vaccines within 28 days before first study drug administration
    17. History of another primary malignancy may be excluded (see protocol)
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of CRS and non-CRS DLTs during the first cycle of treatment (phase 1 only)
    - Type, incidence and severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
    - Changes in laboratory safety parameters and vital signs
    - Overall response rate (ORR) based on best overall response of complete remission, complete remission with partial hematological recovery (CRh); complete remission with incomplete hematological recovery (CRi), morphologic leukemia-free state (MLFS) and
    partial remission (PR) according to the European LeukemiaNet (ELN) response criteria 2022 (phase 2a only)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Variable. For example, certain assessments will be performed at screening, at week 4, 8 and 12 after the start of
    study treatment and every 12 weeks (± 1 week) thereafter until PD, withdrawal of consent, death, or study termination, whichever occurs first.
    E.5.2Secondary end point(s)
    - Determination of PK parameters including (but not limited to) Cmax, time at Cmax (Tmax), minimal serum concentration (Cmin), area under the concentration-time curve (AUC), total CL, volume
    of distribution (Vd) and t1/2
    - Different levels of CR, CRh, CRi, MLFS and PR according to the ELN response criteria 2022, separately and pooled
    - Event free survival (EFS) based on ELN response criteria 2022
    - Duration of response (DoR) based on ELN response criteria 2022
    - Overall survival (OS) (phase 2a only)
    - Reduction of granulocyte-colony stimulating factor (G-CSF)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Variable
    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 Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Netherlands
    Switzerland
    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
    The overall EoS is defined as the date when the last patient/last visit occurs or when the last data point required for statistical analysis or safety FU is received from the last patient, whichever occurs later.
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 75
    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)
    As detailed in Protocol OR

    Treatment beyond PD will be allowed if the investigator believes that the patient is still receiving clinical benefit from study treatment and that the potential benefit of continuing study treatment outweighs any potential risk, and only with Sponsor approval.
    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 Decision2022-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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