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First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b

Sponsor
Mersana Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03319628
Collaborator
IQVIA Biotech (Industry), PSI CRO (Industry)
444
Enrollment
148
Locations
5
Arms
72.6
Anticipated Duration (Months)
3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

First-in-human, Phase 1b/2 safety study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks. Patients with tumor types likely to express NaPi2b were enrolled in dose escalation. Patients with platinum-resistant ovarian cancer and non-small cell lung cancer (adenocarcinoma subtype) are being enrolled in the expansion segment of this study. Patients with platinum-resistant, high-grade serous ovarian cancer are being enrolled in the UPLIFT segment of this study. In addition to safety assessments, the pharmacokinetics of the drug will be assessed along with ADC activity. A QTc sub-study has been added for the UPLIFT cohort for a sub-set of sites.

Condition or Disease Intervention/Treatment Phase
  • Drug: upifitamab rilsodotin
 Phase 1/Phase 2

Detailed Description

This is a multi-center study of XMT-1536 (upifitamab rilsodotin) in patients with tumors likely to express NaPi2b, focusing on patients with platinum-resistant ovarian cancer and non-small cell lung cancer, adenocarcinoma subtype. XMT-1536 (upifitamab rilsodotin) will be administered as an intravenous infusion once every four weeks. The study consists of three segments: dose escalation (DES), dose expansion (EXP), and the pivotal cohort (UPLIFT). The DES segment studied small groups of patients who received increased doses. A Safety Review Committee was established to review the data from each dose level before moving to the next higher dose. The dose escalation cohort has ended and is no longer enrolling patients. Enrollment into the EXP segment consists of 2 parallel cohorts of patients to confirm the dose that has been identified in DES and estimate the objective response rate in each patient population. The EXP cohort is no longer enrolling patients. Enrollment into the pivotal cohort (UPLIFT) includes patients with platinum-resistant ovarian cancer. All adverse events will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria version (CTCAE v5.0). Throughout the study, pharmacokinetics will be measured using proprietary assays developed by Mersana. Anti-cancer activity will be measured via RECIST.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
444 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Open-label, dose escalation to reach MTD. The MTD will be confirmed in parallel cohorts: patients with platinum-resistant ovarian cancer; patients with non-squamous NSCLC, adenocarcinoma subtypeOpen-label, dose escalation to reach MTD. The MTD will be confirmed in parallel cohorts: patients with platinum-resistant ovarian cancer; patients with non-squamous NSCLC, adenocarcinoma subtype
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients With Solid Tumors Likely to Express NaPi2b
Actual Study Start Date :
Dec 12, 2017
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose Escalation

XMT-1536 (upifitamab rilsodotin) treatment is administered in groups of patients who will receive doses that increase over time. This cohort is closed to enrollment.

Drug: upifitamab rilsodotin
XMT-1536 will be administered once every 28 days until disease progression, unacceptable toxicity, or either the patient or study physician determines it is in the best interest of the patient to discontinue participation in the study. For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536
Other Names:
  • XMT-1536
  • UpRi

    		•
    Experimental: Dose Expansion - Ovarian Cancer

    Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose. Patients with ovarian cancer will enroll until sites approve UPLIFT.

    Drug: upifitamab rilsodotin
    XMT-1536 will be administered once every 28 days until disease progression, unacceptable toxicity, or either the patient or study physician determines it is in the best interest of the patient to discontinue participation in the study. For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536
    Other Names:
  • XMT-1536
  • UpRi

    		•
    Experimental: Dose Expansion - NSCLC adenocarcinoma

    Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose. This cohort is closed to enrollment.

    Drug: upifitamab rilsodotin
    XMT-1536 will be administered once every 28 days until disease progression, unacceptable toxicity, or either the patient or study physician determines it is in the best interest of the patient to discontinue participation in the study. For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536
    Other Names:
  • XMT-1536
  • UpRi

    		•
    Experimental: Pivotal Cohort (UPLIFT)

    Patients with platinum-resistant ovarian cancer will receive XMT-1536 (upifitamab rilsodotin) to further confirm the efficacy

    Drug: upifitamab rilsodotin
    XMT-1536 will be administered once every 28 days until disease progression, unacceptable toxicity, or either the patient or study physician determines it is in the best interest of the patient to discontinue participation in the study. For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536
    Other Names:
  • XMT-1536
  • UpRi

    		•
    Experimental: QTc Sub-Study

    For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536.

    Drug: upifitamab rilsodotin
    XMT-1536 will be administered once every 28 days until disease progression, unacceptable toxicity, or either the patient or study physician determines it is in the best interest of the patient to discontinue participation in the study. For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536
    Other Names:
  • XMT-1536
  • UpRi

    		•

    Outcome Measures

    Primary Outcome Measures

    1. DES: Maximum tolerated dose or recommended Phase 2 dose [Up to 36 weeks, from the date of first dose until unacceptable side effects or a dose-limiting toxicity is met]

      Evaluate adverse events and concomitant medication use after XMT-1536 (upifitamab rilsodotin) doses

    2. DES and EXP: Safety and Tolerability [First dose up until 30 days after study termination]

      Evaluate incidence and severity of adverse events

    3. EXP: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin) [Every 6 weeks for up to 36 weeks]

      Monitor tumor size

    4. UPLIFT: Investigator-assessed objective response rate (ORR) of XMT-1536 (upifitamab rilsodotin) in the ITT-Higher NaPi2b population [Every 8 weeks until disease progression or up to 24 months]

      Confirmed ORR is defined as the proportion of patients who have achieved a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 after the initiation of study treatment.

    5. QTc Sub-study: Evaluation of the concentration response analysis of XMT-1536 versus the change in QTcF values [60 minutes prior to first dose, up to 26 hours after Cycle 3 dose]

      "The concentration-QTcf change from baseline deltaQTcF analysis and analysis of central tendency for deltaQTcF

    Secondary Outcome Measures

    1. DES and EXP: Time of maximum observed concentration of XMT-1536 (upifitamab rilsodotin) [Daily for one week after first dose; weekly until 28 days after first dose; immediately before and after and 1 week after all subsequent doses]

      Determine the pharmacokinetics of XMT-1536 (upifitamab rilsodotin)

    2. DES and EXP: Maximum concentration of XMT-1536 (upifitamab rilsodotin) [Daily for one week after first dose; weekly until 28 days after first dose; immediately before and after and 1 week after all subsequent doses]

      Determine the pharmacokinetics of XMT-1536 (upifitamab rilsodotin)

    3. DES and EXP: Area under the concentration curve of the last measurable concentration of XMT-1536 (upifitamab rilsodotin) [Daily for one week after first dose; weekly until 28 days after first dose; immediately before and after and 1 week after all subsequent doses]

      Determine the pharmacokinetics of XMT-1536 (upifitamab rilsodotin)

    4. DES: Anti-neoplastic effects of XMT-1536 (upifitamab rilsodotin) [Every 6 weeks for up to 36 weeks]

      Monitor tumor size

    5. DES and EXP: Anti-drug antibody and neutralizing antibody [Every 6 weeks for up to 36 weeks]

      Analyze blood for antibodies to XMT-1536 (upifitamab rilsodotin) and neutralizing antibodies

    6. UPLIFT: Investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) regardless of NaPi2b expression [Every 8 weeks until disease progression or up to 24 months]

      Assess the investigator-assessed objective response rate of XMT-1536 (upifitamab rilsodotin) regardless of NaPi2b expression

    7. UPLIFT: Objective response rate by independent radiology review (IRR) for patients with higher NaPi2b and overall [Every 8 weeks until disease progression or up to 24 months]

      Assess the objective response rate by IRR for patients with higher NaPi2b and overall

    8. UPLIFT: Duration of objective response (DOR) [4 weeks after first response and every 8 weeks until disease progression or up to 24 months]

      Assess the duration of objective response (DOR) in patients who achieve a response

    9. UPLIFT: Incidence and severity of adverse events [First dose up until 60 days after study termination]

      Evaluate incidence and severity of adverse events

    10. QTc Sub-Study: Evaluation of the effect of XMT-1536 on QTcF in patients with platinum-resistant HGSOC by timepoint analysis [60 minutes prior to first dose, up to 26 hours after Cycle 3 dose]

      Con.-QTc evaluation

    11. QTc Sub-Study: Evaluation of the effect of XMT-1536 on the PR-interval (PR), QRS duration (QRS), Heart Rate (HR), and ECG morphology [60 minutes prior to first dose, up to 26 hours after Cycle 3 dose]

      Con.-QTc evaluation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    General Inclusion Criteria (for Dose Escalation, Expansion, and UPLIFT):

    • ECOG performance status 0 or 1

    • Measurable disease as per RECIST, version 1.1

    • 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).

    • Cardiac left ventricular ejection fraction (LVEF) ≥50% or ≥ the institution's lower limit of normal by either Echo or MUGA scan

    • Adequate organ function as defined by the following criteria:

    1. Absolute neutrophil count (ANC) ≥1500 cells/mm3

    2. Platelet count ≥100,000/mm3

    3. Hemoglobin ≥9 g/dL

    4. In patients not on anticoagulation therapy: INR, activated partial thromboplastin time (aPTT), and prothrombin time (PT) all within 1.2 times the institution's upper limit of normal (ULN). Patients on anticoagulation therapy are allowed if their relevant laboratory values are within the therapeutic window.

    5. Estimated glomerular filtration rate (GFR) ≥45 mL/min

    6. Total bilirubin ≤ULN

      1. Patients with asymptomatic elevations in unconjugated bilirubin due to Gilbert syndrome or stable chronic hemolytic anemia (e.g., hereditary spherocytosis, sickle cell disease, thalassemia intermedia) may be eligible after discussion with the Sponsor Medical Monitor.

    • Aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤1.5 times the institutional ULN.

    • Albumin ≥3.0 g/dL

    • Able to provide informed consent.

    General Exclusion Criteria (for Dose Escalation, Expansion, and UPLIFT) :

    • 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, or recent radiation therapy with unresolved toxicity or within a time window of potential toxicity.

    • Patients with untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.

    • Current known active infection with HIV, hepatitis B virus, or hepatitis C virus.

    • Prior history of liver disease such as liver cirrhosis, hepatic fibrosis

    • Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could interfere with per-protocol evaluations.

    • Current use of either constant or intermittent supplementary oxygen therapy.

    • History of suspected pneumonitis or interstitial lung disease.

    • Pregnant or nursing women.

    • History of other malignancy within the last 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.

    • Active corneal disease, or history of corneal disease within 12 months prior to enrollment

    • Use of strong CYP450 inhibitors

    • Oxygen saturation on room air <93%

    Ovarian Cancer Inclusion Criteria for UPLIFT:

    • Histological diagnosis of high grade serous ovarian cancer, which includes fallopian tube, or primary peritoneal cancer, that is metastatic or recurrent.

    • Platinum-resistant disease

    1. 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

    2. 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

    • One to 4 prior lines of systemic therapy for ovarian cancer
    1. Prior treatment with bevacizumab is required for patients with 1 to 2 prior lines of therapy
    • 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
    Ovarian Cancer Exclusion Criteria for UPLIFT:

    • Low-grade, clear cell, endometrioid, mucinous, carcinosarcoma, germ-cell, mixed histology, or stromal tumors

    • Prior treatment with mirvetuximab soravtansine or another ADC containing an antitubulin payload

    • Primary platinum-resistant disease, defined by a lack of response or by progression within 3 months after completing front-line, platinum-containing therapy.

    • Participation in DES or EXP segments of this study

    Ovarian Cancer Inclusion Criteria for QTc sub-study:

    Note: patients must meet all UPLIFT cohort inclusion criteria in order to participate in the QTc sub-study

    • Study patient has agreed to remain in the clinic for the additional QTc related study activities on the Day 1 of Cycle 1 and Cycle 3.

    Ovarian Cancer Exclusion Criteria for QTc sub-study:

    • Use of strong CYP3A4 inducers.

    • Uncontrolled cardiac arrhythmias, for example, atrial fibrillation with a ventricular response at rest > 100 beats per minute. left bundle branch block (LBBB)

    • Known abnormality of any cardiac valve (either stenosis or regurgitation) that is greater than moderate in severity.

    • Subjects not in sinus rhythm at screening with HR >45- <100

    • Any ECG abnormality that can interfere with the measurement of the QT interval

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 Arizona Oncology Associates, PC - HAL Phoenix Arizona United States 85712
    3 Arizona Oncology Associates Tucson Arizona United States 85712
    4 Cedars Sinai Medical Center Los Angeles California United States 90048
    5 University of California - Irvine Orange California United States 92868
    6 Sansum Clinic Santa Barbara California United States 93105
    7 University of Colorado Boulder Colorado United States 80309
    8 Rocky Mountain Cancer Centers, LLP Lone Tree Colorado United States 80124
    9 University of Florida Gainesville Florida United States 32611
    10 Mayo Clinic - Jacksonville Jacksonville Florida United States 32224
    11 University of Miami - Miller School of Medicine Miami Florida United States 33136
    12 Miami Cancer Institute Miami Florida United States 33176
    13 H. Lee Moffitt Cancer Center Tampa Florida United States 33612
    14 Emory University Atlanta Georgia United States 30322
    15 Georgia Cancer Center at Augusta University Augusta Georgia United States 30912
    16 University of Chicago Chicago Illinois United States 60607
    17 Maryland Oncology and Hematology Bethesda Maryland United States 20817
    18 Massachusetts General Hospital Boston Massachusetts United States 02114
    19 Dana Farber Cancer Insititute Boston Massachusetts United States 02215
    20 Lahey Clinic Burlington Massachusetts United States 01805
    21 Karmanos Cancer Institute Detroit Michigan United States 48201
    22 Henry Ford Medical Center Detroit Michigan United States 48235
    23 QUEST Research Institute Farmington Hills Michigan United States 48334
    24 START - Midwest Grand Rapids Michigan United States 49546
    25 START-Midwest Grand Rapids Michigan United States 49546
    26 University of Minnesota Minneapolis Minnesota United States 55455
    27 Washington University Saint Louis Missouri United States 63130
    28 Billings Clinic Billings Montana United States 59101
    29 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    30 Southwest Women's Oncology- Optimum Clinical Research Group Albuquerque New Mexico United States 87109
    31 Women's Cancer Care Associates, LLC Albany New York United States 12208
    32 NYU Langone Health New York New York United States 10016
    33 Mount Sinai Hospital New York New York United States 10029
    34 Levine Cancer Institute Charlotte North Carolina United States 28204
    35 University of Cincinnati Medical Center Cincinnati Ohio United States 45267
    36 The Ohio State University Wexner Medical Center Columbus Ohio United States 43210
    37 Kattering Medical Center Kettering Ohio United States 45429
    38 Stephenson Cancer Centre-University of Oklahoma Oklahoma City Oklahoma United States 73104
    39 Oklahoma Cancer Specialists and Research Institute Tulsa Oklahoma United States 74146
    40 Willamette Valley Cancer Institute Eugene Oregon United States 97401
    41 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    42 University of Pittsburgh Hillman Cancer Center Pittsburgh Pennsylvania United States 15218
    43 Allegheny Health Network Pittsburgh Pennsylvania United States 15222
    44 Women & Infants Hospital of Rhode Island Providence Rhode Island United States 02905
    45 Medical University of South Carolina Charleston South Carolina United States 29425
    46 Institute of Transnational Oncology-Greenville Hospital System University Medical Center Greenville South Carolina United States 29604
    47 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    48 University of Tennessee Knoxville Tennessee United States 37996
    49 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    50 Texas Oncology, Austin Austin Texas United States 78705
    51 Texas Oncology-Austin Austin Texas United States 78731
    52 Texas Oncology- Bedford Bedford Texas United States 76022
    53 Mary Crowley Cancer Research Center Dallas Texas United States 75201
    54 Texas Oncology Baylor Charles A. Sammons Cancer Center Dallas Texas United States 75246
    55 Texas Oncology, Fort Worth Fort Worth Texas United States 76104
    56 Baylor College of Medicine Houston Texas United States 77030
    57 Texas Oncology, Houston Houston Texas United States 77030
    58 South Texas Accelerated Research Therapeutics (START) San Antonio Texas United States 78229
    59 NEXT Oncology San Antonio Texas United States 78240
    60 University of Utah Huntsman Cancer Institute Salt Lake City Utah United States 84112
    61 University of Virginia- Emily Couric Clinical Cancer Center Charlottesville Virginia United States 22903
    62 Virginia Cancer Specialist Fairfax Virginia United States 22031
    63 Virginia Commonwealth University Massey Cancer Center Richmond Virginia United States 23298
    64 BlueRidge Cancer Care Physicians Roanoke Virginia United States 24014
    65 University of Washington Seattle Washington United States 98195
    66 Medical College Of Wisconsin Madison Wisconsin United States 53226
    67 Austin Health - Olivia Newton John Cancer Center Heidelberg Victoria Australia
    68 Blacktown Road Blacktown Australia 2148
    69 Chris OBrien Lifehouse Camperdown Australia 2050
    70 Chris O'Brien Lifehouse Camperdown Australia
    71 Royal Brisbane and Women's Hospital Herston Australia 4029
    72 Peter MacCallum Cancer Center Melbourne Australia 3000
    73 Icon Cancer Centre South Brisbane South Brisbane Australia 4201
    74 University Hospital Graz Graz Austria 8036
    75 University Hospital Innsbruck - Tyrolean Hospital Innsbruck Austria 6020
    76 Our Dear Lady Hospital, Aalst Campus Aalst Belgium 9300
    77 Saint Luc University Hospital Brussel Belgium 1200
    78 Campus Kennedylaan, President Kennedylaan 4 Kortrijk Belgium 8500
    79 Herestraat 49 Leuven Belgium 3000
    80 Avenue de l'Hopital 1 Liège Belgium 4000
    81 Multiprofile Hospital for Active Treatment" Park Hospital EOOD Branipole Bulgaria 4109
    82 Complex Oncology Center - Burgas Burgas Bulgaria 8000
    83 Multiprofile Hospital for Active Treatment "Serdika", Sofia Sofia Bulgaria 1303
    84 MHAT for Women's Health "Nadezhda" Sofia Bulgaria 1330
    85 Multiprofile Hospital for Active Treatment "Sofiamed", Sofia Sofia Bulgaria 1797
    86 Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte Sofia Bulgaria 4500
    87 British Columbia Cancer Agency Vancouver British Columbia Canada
    88 McGill University Health Centre - The Montreal General Hospital Montreal Quebec Canada
    89 Tom Baker Cancer Center Calgary Canada T2N 4N2
    90 Sherbrooke University Hospital Centre Québec Canada J1G 2E8
    91 Princess Margaret Cancer Centre Toronto Canada M5G 2M9
    92 University Hospital Brno Brno Czechia 625 00
    93 General University Hospital in Prague Prague Czechia 110 00
    94 University Hospital Bulovka Prague Czechia 180 81
    95 Rigshospitalet - University Hospital Copenhagen Copenhagen Denmark DK-2100
    96 Odense University Hospital Odense Denmark DK-5230
    97 Tampere University Hospital Tampere Finland 33520
    98 Francois Baclesse Center Caen France 14076
    99 Leon Berard Center Montpellier France 34298
    100 Montpellier Cancer Institute Montpellier France 34298
    101 Confluent Private Hospital Nantes France 44277
    102 South Lyon Hospital Center, Department of Clinical Hematology Pierre-Bénite France 69495
    103 Strasbourg Europe Institut of Cancerology Strasbourg France 23025
    104 Institute Claudius Regaud Toulouse France 31059
    105 Gustave Roussy Villejuif France 94805
    106 National Institute of Oncology Budapest Hungary 1122
    107 University of Debrecen Clinical Center Debrecen Hungary 4032
    108 Petz Aladar University Teaching Hospital Gyor Hungary 9024
    109 Petz Aladar University Teaching Hospital Győr Hungary 9024
    110 Polyclinic S. Orsola-Malpighi Bologna Italy 40138
    111 Hospital Cannizzaro - Catania Catania Italy 95126
    112 Hospital San Raffaele, IRCCS Milan Italy 20132
    113 National Cancer Institute - IRCCS "Fondazione G. Pascale" Naples Italy 80131
    114 University Hospital Campus Bio-Medico Rome Italy 00128
    115 National Cancer Institute Regina Elena, IRCCS Rome Italy 00144
    116 University Polyclinic Foundation "Agostino Gemelli" - IRCCS Rome Italy 00168
    117 Institute of Cancer Research and Treatment of Candiolo Turin Italy 10060
    118 National Cancer Institute Vilnius Lithuania 08660
    119 Vilnius University Hospital Santaros Klinikos Vilnius Lithuania 08661
    120 Auckland District Health Board, Auckland City Hospital Auckland New Zealand 1023
    121 Oslo University Hospital, Rikshospitalet (The National Hospital) Oslo Norway 0372
    122 Maria Sklodowska-Curie Bialystok Oncology Center Białystok Poland 15-027
    123 University Teaching Hospital in Bialystok Białystok Poland 15-276
    124 University Clinical Center, Clinic of Gynecology Gdańsk Poland 80-214
    125 Provincial Hospitals in Gdynia Sp. z o.o. (LLC) Gdynia Poland 81-519
    126 Heliodor Swiecicki Clinical Hospital at the Karol Marcinkowski Medical University in Poznan Poznań Poland 60-569
    127 University Hospital Germans Trias i Pujol Badalona Spain 08916
    128 University Hospital Vall d'Hebron Barcelona Spain 08035
    129 Hospital Clinic of Barcelona Barcelona Spain 08036
    130 University Clinical Hospital Virgen de la Arrixaca El Palmar Spain 30120
    131 Jaen Hospital Complex Jaen Spain 23007
    132 Clinica Univ di Navarra Madrid Spain 28027
    133 Navarra University Clinic Madrid Spain 28027
    134 University Hospital Clinical San Carlos Madrid Spain 28040
    135 University Hospital Foundation Jimenez Diaz Madrid Spain 28040
    136 Hospital Universitario La Paz Madrid Spain 28046
    137 La Paz University Hospital Madrid Spain 28046
    138 Clara Campal Comprehensive Cancer Center Madrid Spain 28050
    139 University Hospital Virgen del Rocio (HUVR) Sevilla Spain 41013
    140 University Clinical Hospital of Valencia Valencia Spain 46010
    141 Lund University, Department of Oncology Lund Sweden 22100
    142 Addenbrooke's Hospital Cambridge United Kingdom CB2 0QQ
    143 Beatson West of Scotland Cancer Center Glasgow United Kingdom G12 0YN
    144 University College London Hospitals NHS Foundation Trust London United Kingdom NW1 2PG
    145 Guy's Hospital London United Kingdom SE1 9RT
    146 Royal Marsden Hospital - London, Gynae Trials Unit London United Kingdom SM2 5PT
    147 The Christie NHS Foundation Trust Manchester United Kingdom M20 4BX
    148 Mount Vernon Hospital, Cancer Center Northwood United Kingdom HA6 2RN

    Sponsors and Collaborators

    • Mersana Therapeutics
    • IQVIA Biotech
    • PSI CRO

    Investigators

    • Study Director: Leslie DeMars, MD, Mersana Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mersana Therapeutics
    ClinicalTrials.gov Identifier:
    NCT03319628
    Other Study ID Numbers:
    • XMT-1536-1
    First Posted:
    Oct 24, 2017
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 8, 2022