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    Summary
    EudraCT Number:2020-000630-17
    Sponsor's Protocol Code Number:MER-XMT-1536-1
    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:2021-07-19
    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 number2020-000630-17
    A.3Full title of the trial
    A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A dose escalation and expansion study of XMT-1536 en patients with solid tumors.
    A.4.1Sponsor's protocol code numberMER-XMT-1536-1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03319628
    A.5.4Other Identifiers
    Name:IND numberNumber:135,571
    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 SponsorMersana Therapeutics, 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 supportMersana Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMersana Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address840 Memorial Drive
    B.5.3.2Town/ cityCambridge, Massachusetts
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.6E-mailXMT-1536-Clinical@mersana.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 nameUpifitamab rilsodotin
    D.3.2Product code XMT-1536
    D.3.4Pharmaceutical form Powder for injection
    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 INNUpifitamab Rilsodotin
    D.3.9.1CAS number 2254119-00-9
    D.3.9.2Current sponsor codeXMT-1536
    D.3.9.3Other descriptive nameXMT-1536
    D.3.9.4EV Substance CodeSUB193958
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 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
    High grade serous ovarian cancer
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    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
    Primary in Pivotal Cohort (UPLIFT):
    Determine the confirmed investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) at a starting dose level of 36 mg/m2 q4wk capped at 2.2 m2 in patients with higher (TPS ≥75) sodium-dependent phosphate transport protein 2b (NaPi2b) expressing platinum-resistant high-grade serous ovarian cancer (HGSOC), including cancers of ovarian, fallopian tube or primary peritoneal origin)
    E.2.2Secondary objectives of the trial
    Secondary in UPLIFT:
    - Assess confirmed investigator-assessed objective response rate of XMT-1536 regardless of NaPi2b expression.
    - Assess confirmed objective response rate by indep radiology review (IRR) for patients with high (TPS =75) NaPi2b and overall.
    - Assess duration of objective response (DOR) in patients who achieve a response.
    - Assess incidence and severity of adverse events.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For Dose Escalation, Expansion and Uplift
    1. Females and males, aged ≥18 years old
    2. ECOG performance status 0 or 1
    3. Measurable disease as per RECIST, version 1.1
    4. Resolution of all acute toxic effects of prior therapy or surgical procedures to ≤Grade 1 (except alopecia, stable immune-related toxicity such as hypothyroidism on hormone replacement, adrenal insufficiency on ≤10 mg daily [prednisone] (or equivalent) chronic Grade 2 peripheral sensory neuropathy after prior taxane therapy).
    5. Cardiac left ventricular ejection fraction (LVEF) ≥50% or ≥ the institution’s lower limit of normal by either Echo or MUGA scan
    6. Adequate organ function as defined by the following criteria:
    a. Absolute neutrophil count (ANC) ≥1500 cells/mm3
    b. Platelet count ≥100,000/mm3
    c. Hemoglobin ≥9 g/dL
    d. In patients not on anticoagulation therapy: INR, activated partial thromboplastin time (aPTT), and prothrombin time (PT) all within 1.2 times the institutional upper limit of normal (ULN) in the absence of any other indicator of liver dysfunction. Patients on anticoagulants are allowed if their relevant laboratory values are within the therapeutic
    window.
    e. Estimated glomerular filtration rate (GFR) ≥45 mL/min
    f. Total bilirubin ≤ULN
    Patients with asymptomatic elevations in unconjugated bilirubin due to Gilbert syndrome or stable chronic hemolytic anemia may be eligible after discussion with the Sponsor Medical Monitor.
    7. Aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤1.5 times the institutional ULN.
    8. Albumin ≥3.0 g/dL
    9. Female participants of child-bearing potential must use a highly effective non-hormonal form of contraception for the duration of study drug administration and for at least 6 months after the last dose of study drug.
    Please see Appendix 7 of the Protocol for examples of non-hormonal highly effective contraceptive methods.
    10. Male study participants must use barrier contraception (condoms) for the duration of study drug and for at least 6 months after the last dose of study drug. The WOCBP partners of male study participants must use highly effective contraception for the duration of study drug and for at least 6 months after the last dose of study drug
    11. Able to provide informed consent
    for UPLIFT
    1. Histological diagnosis of high grade serous ovarian cancer, which includes fallopian tube, or primary peritoneal cancer, that is metastatic or recurrent
    2. Platinum-resistant disease
    a. Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response [complete response/remission (CR) or partial response/remission (PR)], and then progressed between 3 months and ≤ 6 months after the date of the last dose of platinum
    b. Patients who have received 2 to 4 lines of prior therapy must have received at least 4 cycles of platinum and then progressed within 6 months after the date of the last dose of platinum
    3. One to 4 prior lines of systemic therapy for ovarian cancer
    a. Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy.
    b. Definitions for prior lines of therapy:
    i. Adjuvant ± neoadjuvant considered one line of therapy as long as they are the same regimens (e.g., platinum/taxane for 4 cycles before surgery followed by platinum/taxane for 4 cycles after surgery)
    ii. Maintenance therapy (e.g., bevacizumab, PARPi, endocrine therapy) will be considered as part of the preceding line of therapy (i.e., not counted independently)
    iii. Therapy given for only 1 cycle and changed due to toxicity in the absence of progression will be considered as part of the same line (i.e., not counted independently); therapy given for 2 or more cycles will be counted as a new line
    iv. Hormonal therapy (e.g., tamoxifen, letrozole) will be counted as a separate line of therapy unless it was given as maintenance
    4. Patients must be willing to provide an archival tumor tissue block or slides or if not available, undergo procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure
    E.4Principal exclusion criteria
    For Dose Escalation, Expansion and Uplift
    1. Major surgery within 28 days of starting study treatment, systemic anti-cancer therapy within the lesser of 28 days or 5 half-lives of the prior therapy before starting study treatment (14 days or 5 half-lives for small molecule targeted therapy), or recent radiation therapy with unresolved toxicity or within a time window of potential toxicity (consultation with the Sponsor Medical Monitor is recommended).
    2. Patients with untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.
    a. Patients are eligible if CNS metastases are adequately treated and patients are neurologically stable for at least 2 weeks prior to enrollment.
    b. In addition, patients must be either off corticosteroids, or on a stable/decreasing dose of ≤ 10 mg daily prednisone (or equivalent). Anticonvulsants are allowed except for those drugs associated with liver toxicity.
    3. Untreated known human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). In addition, negative serology is required during screening (baseline) for HBV and HCV:
    a. HBV: Patients with serologic evidence of chronic HBV infection should have an HBV viral load below the limit of quantification to be eligible.
    b. HCV: Patients with a history of HCV infection should have completed curative antiviral treatment and HCV viral load below the limit of quantification.
    c. HIV: screening for HIV is not required except if mandated by local regulations or indicated based on clinical assessment.
    4. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could risk of adverse events, whether or not potentially related to study treatment (in unclear cases, consultation
    with the Medical Monitor is recommended). Further, patients are excluded with the following characteristics:
    a. A marked baseline prolongation of QT/QTc interval using Frederica's QT correction formula.
    b. A history of additional risk factors for Torsade's de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
    c. The use of concomitant medications that prolong the QT/QTc interval will be reviewed first with the Sponsor Medical Monitor.
    5. History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver disease. FibroScan testing may be required for patients with a history of chronic liver disease, e.g., fatty liver. Testing beyond laboratory studies otherwise defined in the eligibility criteria, to diagnose potentially clinically significant liver disease based on risk factors such as hepatic steatosis or history of excessive alcohol intake, will be based on clinical judgement of the investigator.
    6. Patients cannot receive drugs associated with hepatotoxicity concurrent with XMT-1536 administration. Patients may receive acetaminophen/paracetamol for a limited time but at a total daily dose of ≤2 g per day. Use of NSAIDs or steroids for treatment of fever is encouraged.
    7. Current use of either constant or intermittent supplementary oxygen therapy.
    8. History of or suspected pneumonitis, or interstitial lung disease.
    9. Oxygen saturation on room air <93%.
    10. Pregnant or nursing women.
    11.Diagnosis of additional malignancy that progressed or required active treatment within at least 2 years , except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix
    12. Active corneal disease, or history of corneal disease within 12 months prior to enrollment.
    13. Use of strong CYP450 inhibitors 3A inhibitors or inducers that cannot be discontinued while receiving study treatment..
    14. Known sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
    15. In the Czech Republic, patients cannot be enrolled if they have received a live/attenuated vaccine within 30 days of study entry or if
    they plan to receive a live/attenuated vaccine while on treatment through 90 days post the last dose of study medication

    Ovarian Cancer Exclusion Criteria for UPLIFT – Cohort
    1. Low-grade, clear cell, endometrioid, mucinous, carcinosarcoma, germ-cell, mixed histology, or stromal tumors
    2. Prior treatment with mirvetuximab soravtansine or another ADC containing an antitubulin payload
    3. Primary platinum-resistant disease, defined by a lack of response or by progression within 3 months after completing front-line, platinum-containing therapy.
    4. Participation in DES or EXP segments of this study
    E.5 End points
    E.5.1Primary end point(s)
    For UPLIFT:
    Objective Response Rate (ORR) in the ITT-Higher NaPi2b population
    E.5.1.1Timepoint(s) of evaluation of this end point
    For UPLIFT:
    - Derived at the end of the study using a composite of RECIST evaluations that are compared to each patient’s baseline measurement and subsequent post-baseline measurements
    E.5.2Secondary end point(s)
    For UPLIFT:
    Confirmed investigator-assessed ORR in the entire ITT population
    ORR by IRR in the ITT-Higher NaPi2b population; ORR by IRR in the entire ITT population
    DOR in the ITT-Higher NaPi2b population
    DOR in the entire ITT population
    Safety and tolerability measures
    E.5.2.1Timepoint(s) of evaluation of this end point
    - for Confirmed investigator-assessed ORR in the entire ITT population, ORR by IRR in the ITT-Higher NaPi2b population and ORR by IRR in the entire population, the timepoint is: derived at the end of the study using a composite of RECIST evaluations that are compared to each patient’s baseline measurement and subsequent post-baseline measurements
    - for DOR in the ITT-Higher NaPi2b population and DOR in the entire ITT population, the timepoint is:
    at the end of the study
    - for Safety and tolerability, the timepoint is: from Day 1 to the end of the study
    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 No
    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 No
    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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Australia
    Canada
    New Zealand
    United States
    Russian Federation
    Belgium
    Bulgaria
    Czechia
    Denmark
    Finland
    France
    Hungary
    Italy
    Lithuania
    Norway
    Poland
    Spain
    Sweden
    United Kingdom
    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
    Subjects will have an End of Treatment Visit (LSLV) and thereafter will be followed for survival via telephone calls every 3 months.
    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 months9
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days20
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 100
    F.4.2.2In the whole clinical trial 240
    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)
    The primary reason for discontinuation from the study is disease progression. At that time, all subsequent treatment will come from a patient’s primary oncologist.
    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 Decision2021-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
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