AzTrials
AzTrials

Solid TumorPhase 1/2NCT04300556

A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types

A Phase 1/2 study testing Farletuzumab ecteribulin, Prednisone and Prednisolone in people with Solid Tumor, run by Eisai Inc. at 58 sites in 5 countries.

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Sites and contacts
Official record
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Trial summary

The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer [OC], endometrial cancer [EC], non-small cell lung… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
Farletuzumab ecteribulin, Prednisone and Prednisolone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
58 sitesin 5 countries
Study dates
6 Aug 2020to 8 Aug 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged >=18 years
  • For Dose-Escalation: Females (TNBC, EC and OC) or males/females (NSCLC, adenocarcinoma). Participants with the following disease characteristics:
  • Participants with the following tumor types, each as a separate arm:
  • TNBC: Histologically confirmed diagnosis of metastatic TNBC (that is, estrogen receptor (ER) negative/progesterone receptor negative/ human epidermal growth factor receptor 2 (HER2) negative (defined as immunohistochemistry (IHC) less than (<) 2 plus (+) or fluorescence in situ hybridization (FISH) negative) breast cancer). Previously treated with at least one line of systemic anticancer therapy (cytotoxic or targeted anticancer agents) in the metastatic setting.
  • NSCLC adenocarcinoma: Histologically or cytologically confirmed metastatic NSCLC adenocarcinoma: participants who have failed previous treatment for metastatic disease, are not indicated or failed epidermal growth factor receptor (EGFR)-, Anaplastic lymphoma kinase (ALK) -, B-Raf proto-oncogene (BRAF) - or c-ros oncogene 1 (ROS1) - targeted therapy, and for whom no alternative standard therapy exists.
  • EC: Histologically confirmed diagnosis of advanced, recurrent or metastatic EC. Relapsed or failure of at least one platinum-based regimen or one immunotherapy-based regimen.
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  • OC or primary peritoneal cancer or fallopian tube cancer: Histologically confirmed diagnosis of high grade serous epithelial ovarian cancer or primary peritoneal cancer or fallopian tube cancer.
  • Participants must have:
  • platinum-resistant disease (defined as progression within 6 months after the last dose of at least 4 cycles of the last platinum containing chemotherapy regimen)
  • received up to 4 lines of systemic therapy post development of platinum resistance.
  • For Dose-Confirmation and Dose Optimization:
  • Note: Only participants with histologically confirmed diagnosis of advanced, recurrent, or metastatic EC will be enrolled at sites in France.
  • High-grade serous ovarian cancer or primary peritoneal cancer or fallopian tube cancer:
  • Platinum-resistant disease:
  • For participant with 1 line of platinum-containing therapy: progression greater than (>) 1 month and less than or equal to (<=) 6 months after the last dose of the first platinum-containing chemotherapy regimen (of at least 4 cycles)
  • For participant with 2-3 lines of platinum-containing therapy: progression during or within 6 months after the last dose of the 2nd or 3rd platinum-containing chemotherapy regimen.
  • Have received up to 3 prior lines of systemic therapy and for whom single-agent therapy is appropriate as the next line of therapy. Participants may have been treated with up to one line of therapy subsequent to determination of platinum-resistance. In Dose Optimization Part B participants may have received up to 3 prior lines of systemic therapy, up to 4 prior lines is permitted for participants who have received prior mirvetuximab soravtansine
  • Neoadjuvant plus/minus (±) adjuvant will be considered 1 line of therapy.
  • Maintenance therapy (example, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy (will not be counted as an independent line of therapy).
  • Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance.
  • Therapy changed due to toxicity in the absence of progression will be considered part of the same line.
  • Endometrial cancer (not enrolled in Dose Optimization Part B):
  • Participants must have histologically confirmed diagnosis of advanced, recurrent, or metastatic EC. All histologic (including carcinosarcoma [no more than one participant at any dose level]) and molecular subtypes will be included. Participants may have been treated with an Immune Checkpoint Inhibitor (ICI) containing regimen (or be ineligible for ICI treatment) and must have had no more than 2 prior regimens (not including adjuvant therapy if progression or recurrent/metastatic disease occurred more than 6 months after the completion of the last cycle of adjuvant therapy).
  • Note: There is no restriction regarding prior hormonal therapy.
  • Available tumor tissue for FRA expression percent (%) by IHC analysis as assessed at a central laboratory. There is no minimum requirement for FRA expression (%). However, the tumor sample must be evaluable for IHC analysis (that is, of sufficient quality with adequate tumor content). Sample resubmission will be permitted for participants with tissue result of "non-evaluable" who are otherwise eligible. Tumor sample submission must be archival formalinfixed, paraffin-embedded (FFPE) tissue block, or unstained slides sectioned within 45 days from the latest FFPE block, or a fresh biopsy sample obtained during screening but prior to initiation of study treatment. Participants who have received prior treatment with mirvetuximab soravtansine will be required to provide a fresh biopsy sample during screening.
  • Radiological disease progression on or after the most recent therapy by investigator assessment.
  • Measurable disease meeting the following criteria (confirmed by central radiographic review, in the Dose-Confirmation Part only):
  • At least one lesion of >1.0 centimeter (cm) in long axis diameter for non-lymph nodes or >1.5 cm in short axis diameter for lymph nodes that is serially measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using either computed tomography (CT) or magnetic resonance imaging (MRI),
  • Lesions that have had external beam radiotherapy (EBRT) or loco-regional therapies such as radiofrequency (RF) ablation must show evidence of PD based on RECIST 1.1 to be deemed a target lesion.
  • ECOG PS of 0 or 1.
  • Participants who are expected to survive a minimum of 3 months after the first administration of the study drug.
  • Adequate renal function as evidenced by serum creatinine less than or equal to (<=) 1.5 milligram per deciliter (mg/dL) or calculated creatinine clearance >=50 milliliter per (mL) /minute according to a 12 or 24 hour urine collection.
  • For Dose Optimization Part B, adequate renal function as evidenced by calculated creatinine clearance >=50 milliliters per minute (mL/min) by Cockcroft-Gault formula.
  • Adequate bone marrow function, as evidenced by:
  • Absolute neutrophil count (ANC) >=1.0*10^9 per liter (/L) (MORAb-202 monotherapy cohorts only)
  • ANC >=1.5*10^9/L (MORAb-202 plus lenvatinib cohorts)
  • Hemoglobin (Hgb) >=9.0 gram per deciliter (g/dL)
  • Platelet count >=75*10^9/L Growth factors or transfusions as per institutional practice, are allowed if needed to achieve the above values. Growth factor and platelet transfusion should not be used within 7 days of initiation of study treatment.
  • Adequate liver function, as evidenced by:
  • Total bilirubin <=1.5*upper limit of normal (ULN) except for unconjugated hyperbilirubinemia (example, Gilbert's syndrome)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3*ULN (in the case of liver metastases <=5*ULN). Participants with Alkaline Phosphatase (ALP) <=3*ULN unless they and are known to have bone metastases in which case higher ALP values will also be allowed.
  • Albumin >3.0 g/dL.
  • Participants must undergo a washout period required from the end of prior treatment to the first administration of the study drug that will be as follows:
  • Prior anticancer therapy:
  • Prior chemotherapy, surgical therapy, radiation therapy: >3 weeks. Prior chest radiotherapy or pneumonectomy is an exclusion.
  • Antibody and other biologic therapeutic agents: >=4 weeks.
  • Endocrine therapy or, small-molecule targeted therapy: >2 weeks.
  • Immunotherapy >=4 weeks.
  • Participants with a history of deep vein thrombosis (DVT) within 3 months of enrollment must be on a stable dose of anticoagulation as demonstrated by appropriate laboratory parameters (depending on the anticoagulant agent) for a minimum of 2 weeks before to starting study treatment. Anticoagulation must continue while on study treatment.
  • Participants at risk for DVT secondary to central venous catheters or with past medical history of DVT or clinical symptoms suggestive of DVT must have venous Doppler ultrasonography to rule out DVT during the screening period and before to initiation of study treatment.
  • If a participant has undergone major surgery, the participant must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
  • Resolution of anticancer therapy-related or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (Grade <=2), anemia ([haemoglobin] Hgb >=9.0 g/dL), and alopecia (any grade).
  • Participant must be willing and able to comply with all aspects of the protocol.
  • Participant must provide written informed consent prior to any study-specific screening procedures.
  • For cohorts where MORAb-202 is used in combination with lenvatinib: Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP <=150/90 millimeter of mercury (mm Hg) and no change in antihypertensive medications within 1 week before the first administration of the study drug.

Who cannot join

  • Participants with endometrial leiomyosarcoma, endometrial stromal sarcoma or other soft tissue sarcoma histology.
  • Participants who received previous treatment with any folate receptor targeting agents, except for mirvetuximab soravtansine in the setting of FRA >=75%.
  • Participants with platinum refractory ovarian cancer (defined as disease progression during the initial platinum-based chemotherapy treatment).
  • Currently enrolled in another clinical study or used any investigational drug or device, which in the opinion of the Sponsor may interfere with the study treatment, within the past 28 days or 5 times the half-life (where prior drug therapy falls under the parameters these Inclusion Criteria should be followed) of any investigational drug preceding informed consent.
  • Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 2 weeks before starting treatment in this study. Brain metastases must be stable for at least 4 weeks on 2 consecutive scans of the brain before starting study treatment.
  • Diagnosed with meningeal carcinomatosis.
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  • Any other invasive malignancy that required treatment (other than definitive surgery) or has shown evidence of recurrence/progression (except for non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the 2 years prior to starting study treatment.
  • Significant cardiovascular impairment. History within 6 months prior to the first dose of study drug of: congestive heart failure greater than New York Heart Association (NYHA) Class II); unstable angina; myocardial infarction; stroke; cardiac arrhythmia associated with hemodynamic instability.
  • In addition, for participants enrolled in the MORAb-202 plus lenvatinib cohorts, significant cardiovascular impairment also includes: History of arterial thromboembolism within 12 months of starting study treatment; Left ventricular ejection fraction (LVEF) <50% or below the institutional normal range determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).Note: Medically controlled arrhythmia is permitted.
  • Clinically significant ECG abnormality, including marked prolonged baseline QT as corrected using Fridericia's formula (QTcF) (repeated demonstration of a QTcF interval >500 milliseconds [ms]). A history of risk factors for torsade de pointes (example, heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolong the QTcF.
  • For participants enrolled in the MORAb-202 plus lenvatinib cohorts, prolongation of the QTcF interval to >480 ms.
  • Known to be Human Immunodeficiency Virus (HIV) positive. Testing at entry not required.
  • Active viral hepatitis (B or C as demonstrated by positive serology). Testing at entry if there are no symptoms or history is not required unless as per local requirements.
  • Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin [ß-hCG] or human chorionic gonadotropin [hCG]) with a minimum sensitivity of 25 International units per liter (IU/L) or equivalent units of ß-hCG [or hCG]. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first administration of the study drug.
  • Females of childbearing potential who
  • within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
  • total abstinence (if it is their preferred and usual lifestyle)*
  • an intrauterine device or intrauterine hormone-releasing system (IUS)
  • a contraceptive implant
  • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) or progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable). Participants using an oral contraceptive (participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 7 months (5*half-life plus 180 days) after study drug discontinuation)
  • bilateral tubal occlusion
  • have a vasectomized partner with confirmed azoospermia
  • do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 7 months (5*half-life plus 180 days) after study drug discontinuation.
  • For sites outside of the EU, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, that is, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide. NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
  • Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
  • For Dose-Escalation only: Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (that is, not of childbearing potential or practicing highly effective contraception throughout the study period and for 7 months (5*half-life plus 180 days) after study drug discontinuation). If the female partner is pregnant, then males who do not agree to use latex or synthetic condoms throughout the study period and for 4 months (5*half-life plus 90 days) after study drug discontinuation. No sperm donation is allowed during the study period and for 4 months (5*half-life plus 90 days) after study drug discontinuation.
  • Pulmonary Function Test (PFT) abnormalities: FEV1/FVC <0.7, FEV1 or FVC <80%, DLCO <80% or less than the lower limit of normal according to local institutional standards.
  • Current ILD/pneumonitis, or ILD/pneumonitis is suspected at Screening or history of interstitial lung disease (ILD)/pneumonitis of any severity including ILD/pneumonitis from prior anticancer therapy.
  • Current infectious pneumonia, history of viral pneumonia (including COVID-19-related infection) with evidence of persistent radiologic abnormalities.
  • Lung-specific clinically significant illnesses including, but not limited to any underlying pulmonary disorder (example, pulmonary embolism), asthma, chronic obstructive pulmonary disease (COPD), and restrictive lung disease, or currently receiving any medication that is associated with a clinically significant risk of developing ILD.
  • Clinically significant pleural or pericardial effusion requiring drainage or ascites requiring peritoneal shunt.
  • Prior pneumonectomy.
  • History of chest radiotherapy. Participants with history of chest wall radiation (example, history of breast cancer) may be permitted if chest wall radiation is documented > 2 years before starting study treatment.
  • Any autoimmune, connective tissue, or inflammatory disorders (example, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc) where there is documented (or suspicion of) pulmonary involvement.
  • A known history of active TB (bacillus tuberculosis).
  • Scheduled for surgery during the study, other than minor surgery which would not delay study treatment.
  • An active clinically significant (in the opinion of the Investigator) infection requiring systemic therapy within 2 weeks prior to the first dose of study drug.
  • Administration of a live, attenuated vaccine within 4 weeks prior to the first dose of study drug, or anticipation that such a live attenuated vaccine will be required during the study. Inactivated vaccines (such as hepatitis A or polio vaccines) are permitted during the study. Seasonal influenza and COVID-19 vaccines that do not contain live virus are permitted.
  • Any prior hypersensitivity to monoclonal antibodies or contraindication to the receipt of corticosteroids or any of the excipients (investigators should refer to the prescribing information for the selected corticosteroid).
  • Known intolerance to either of the components of the study drug.
  • Any medical or other condition which, in the opinion of the investigator would preclude the participants participation in the clinical study.
  • Receiving any medication prohibited in combination with the study treatment(s) as described in the product label for eribulin, unless medication was stopped within 7 days prior to enrollment.
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Dose Optimization Part B participants who receiving MORAb-202 in combination with lenvatinib:
  • >1+ proteinuria on dipstick, 24-hour urine protein is >=1 gram.
  • Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.
  • Unable to take oral medication.
  • Major surgery within 3 weeks before the first dose of study treatment. Note: adequate wound healing after major surgery must be assessed clinically and independent of time elapsed for eligibility.
  • Serious nonhealing wound, ulcer or bone fracture.
  • Pre-existing Grade >=3 gastrointestinal (GI) or non-GI fistula.
  • Radiographic evidence of major blood vessel invasion/infiltration. The degree of tumor invasion / infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy.

Trial locations and contacts

58 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Eisai Medical Information contact

1-888-274-2378

esi_oncmedinfo@eisai.com

58 sites in 5 countries

United States24 sites, 5 recruiting

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

    Completed

  • Georgia Cancer Center

    Augusta, Georgia, 30912

    Recruiting

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287

    Completed

  • MD Anderson Cancer Center at Cooper

    Camden, New Jersey, 08103

    Completed

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Withdrawn

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, 22903

    Completed

  • Chattanooga's Program in Women's Oncology

    Chattanooga, Tennessee, 37403

    Completed

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Completed

  • University of Miami

    Coral Gables, Florida, 33146

    Completed

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Completed

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Withdrawn

  • OSU Wxner Medical Center

    Hilliard, Ohio, 43026

    Withdrawn

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Withdrawn

  • Universty of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Completed

  • Norton Healthcare

    Louisville, Kentucky, 40202

    Withdrawn

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 07677

    Withdrawn

  • Columbia University Medical Center

    New York, New York, 10032

    Completed

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • Stanford Women's Cancer Center

    Palo Alto, California, 94304

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Withdrawn

  • Ascension Illinois-Skokie Infustion Center

    Skokie, Illinois, 60077

    Withdrawn

  • Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

    Recruiting

  • ACRC/Arizona Clinical Research Center, Inc

    Tucson, Arizona, 85715

    Withdrawn

Other trials in United States

France14 sites

  • Centre Hospitalier de La Côte Basque

    Bayonne, Pyrenees-Atlantiques, 64109

    Completed

  • Centre François Baclesse

    Caen, Calvados, 1400

    Completed

  • Centre Oscar Lambret

    Lille, Nord, 59000

    Completed

  • Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

    Lyon, Rhone, 69008

    Completed

  • Institut Paoli Calmettes

    Marseille, Bouches-du-Rhone, 13009

    Completed

  • Hopitaux de La Timone

    Marseille, Bouches-du-Rhone, 13385

    Completed

  • EDOG Institut de Cancerologie de l'Ouest

    Nantes, Loir-Atlantique, 44000

    Completed

  • Clinique Catherine de Sienne

    Nantes, Loir-Atlantique, 44200

    Withdrawn

  • Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer

    Nice, Alpes-Maritimes, 06100

    Completed

  • Hôpital de la Croix Saint-Simon

    Paris, 75020

    Completed

  • Hopital Cochin

    Paris, 75679

    Completed

  • Clinique Armoricaine de Radiologie-PPDS

    Saint-Brieuc, Cote-d'Amore, 22000

    Withdrawn

  • ICANS - Institut de cancérologie Strasbourg Europe

    Strasbourg, Bas-Rhin, 67200

    Completed

  • CLCC-Gustave Roussy Cancer

    Vilejuif, Val-de-Marne, 94805

    Completed

Other trials in France

Spain10 sites, 3 recruiting

  • ICO Badalona-H.U. Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

    Completed

  • Clinica Universidad de Navarra

    Madrid, 28027

    Completed

  • Hospital Clinico San Carlos

    Madrid, 28040

    Completed

  • Hospital Universitario Ramon y Cajal

    Madrid, 28304

    Completed

  • Hospital Universitario de Toledo

    Toledo, 45007

    Completed

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, 46009

    Completed

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

    Recruiting

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46013

    Completed

Other trials in Spain

United Kingdom8 sites

  • Belfast City Hospital

    Belfast, Antrim, BT9 7AB

    Withdrawn

  • Velindre Cancer Centre-PPDS

    Cardiff, South Glamorgan, CF14 2TL

    Completed

  • Beatson West of Scotland Cancer Centre-PPDS

    Glasgow, Glasgow City, G12 0YN

    Completed

  • Guy's and St Thomas's Hospital

    London, London, City of, SE1 9RT

    Completed

  • The Christie NHS Foundation Trust

    Manchester, Lancanshire, M20 4BX

    Completed

  • Mount Vernon Cancer Centre

    Northwood, Middlesex, HA6 2RN

    Completed

  • Lancashire Clinical Research Facility, Royal Preston Hospital

    Preston, Lancanshire, PR2 9HT

    Completed

  • The Royal Marsden in Sutton

    Sutton, Surrey, SM2 5PT

    Withdrawn

Other trials in United Kingdom

Japan2 sites, 2 recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 1040045

    Recruiting

  • Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, 1358550

    Recruiting

Other trials in Japan

About this study

Official title: A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types

The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer [OC], endometrial cancer [EC], non-small cell lung carcinoma [NSCLC], triple-negative breast cancer [TNBC]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A [OC and EC participants] and Part B [OC only]): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days; and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to evaluate the safety and tolerability of different doses of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib and to determine the recommended dose (RD) of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib.

Conditions
Solid Tumor
Being tested
Farletuzumab ecteribulin, Prednisone, Prednisolone, Dexamethasone, Lenvatinib
Keywords
Lenvatinib, Farletuzumab ecteribulin, Neoplasms, Endometrial Neoplasms, Triple-Negative Breast Cancer, Endometrial Carcinoma, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Ovarian Neoplasms, Folate Receptor Alpha (FRA)
Medical subject headings
Neoplasms, Endometrial Neoplasms, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Farletuzumab ecteribulinDrug

    Also called MORAb-202

    Farletuzumab ecteribulin intravenous infusion.

  • PrednisoneDrug

    Prednisone administered orally.

  • PrednisoloneDrug

    Prednisolone administered orally.

  • DexamethasoneDrug

    Dexamethasone administered orally.

  • LenvatinibDrug

    Lenvatinib administered orally.

Study groups in NCT04300556
Study groupRoleWhat they receive
Dose Escalation Part: Farletuzumab ecteribulinExperimentalParticipants with selected tumor types will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once every 3 weeks in a 21-day cycle.
Receives: Drug: Farletuzumab ecteribulin
Dose Confirmation Part: Farletuzumab ecteribulinExperimentalParticipants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once every 3 weeks in a 21-day cycle.
Receives: Drug: Farletuzumab ecteribulin
Dose Optimization Part A, Cohort 1: Farletuzumab ecteribulin + Oral CorticosteroidsExperimentalParticipants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion and oral corticosteroids in a 21-day cycle.
Receives: Drug: Farletuzumab ecteribulin; Drug: Prednisone; Drug: Prednisolone; Drug: Dexamethasone
Dose Optimization Part A, Cohort 2: Farletuzumab ecteribulinExperimentalParticipants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion on three different days in a 21-day cycle.
Receives: Drug: Farletuzumab ecteribulin
Dose Optimization Part A, Cohort 3: Farletuzumab ecteribulinExperimentalParticipants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion on two different days in a 21-day cycle.
Receives: Drug: Farletuzumab ecteribulin
Dose Optimization Part B: Farletuzumab ecteribulin + LenvatinibExperimentalParticipants with OC will either receive farletuzumab ecteribulin (MORAb-202) monotherapy as an intravenous infusion or in combination with lenvatinib, orally in a 21-day cycle.
Receives: Drug: Farletuzumab ecteribulin; Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Escalation Part: Recommended Phase 2 Dose (RP2D) of Farletuzumab Ecteribulin

    Measured: Cycle 1 (Cycle length is equal to [=] 21 days)

  2. Dose Optimization Part B: Recommended Dose (RD) of Farletuzumab Ecteribulin Monotherapy and in Combination With Lenvatinib

    Measured: Up to approximately 5 years

  3. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the investigator assessment of radiologic response according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.

    Measured: From date of first dose of study drug until first documentation of CR or PR (up to approximately 24 weeks)

  4. Number of Participants With Dose-limiting Toxicities (DLTs)

    DLTs are any of the toxicities occurring during Cycle 1 and assessed by the investigator as related to study drug. Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE 5.0).

    Measured: Cycle 1 (Cycle length=21 days)

  5. Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Treatment Discontinuation and Adverse Events of Interest (AEIs)

    AE: as any untoward medical occurrence in a participant administered with an investigational product. SAE: as any untoward medical occurrence that at any dose; resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted incongenital anomaly/birth defect. AEIs are AEs that may be associated with the use of immunomodulatory drugs, such as infections, malignancies, autoimmune disorders, and injection reactions. Number of participants with AEIs were reported based on safety assessment of participants with interstitial lung disease (ILD), severity of ILD, time to resolution and onset of ILD symptoms and deaths due to ILD.

    Measured: Baseline up to 28 days after the last dose of study drug (up to approximately 5 years)

Secondary outcomes (14)

  1. Duration of Response (DOR)

    DOR is defined as the time from the first date of documented CR or PR to the date of disease progression or death, whichever occurs first. It will be calculated for participants whose BOR is CR or PR. DOR will be assessed according to RECIST version 1.1.

    Measured: From first documented CR or PR until first documentation of recurrent or progressive disease or death (up to approximately 5 years)

  2. Disease Control Rate (DCR)

    DCR is defined as the percentage of participants with BOR of CR, PR, or stable disease (SD). DCR will be assessed according to RECIST version 1.1.

    Measured: From first dose of study drug until first documentation of CR or PR or SD (up to approximately 5 years)

  3. Clinical Benefit Rate (CBR)

    CBR is defined as the percentage of participants with BOR of CR, PR, or durable SD (duration of SD greater than or equal to [>=] 5 weeks). Duration of SD is defined as the time from the date of first dose to the date of the first documentation of disease progression or death, whichever occurs first. It will be calculated for participants whose BOR is SD. CBR will be assessed according to RECIST version 1.1.

    Measured: From first dose of study drug until disease progression or death, whichever occurs first (up to approximately 5 years)

  4. Progression Free Survival (PFS)

    PFS is defined as the time from the date of first dose to the date of the first documentation of disease progression or death, whichever occurs first. PFS will be assessed according to RECIST version 1.1.

    Measured: From first dose of study drug until disease progression, death, whichever occurs first (up to approximately 5 years)

  5. Overall Survival (OS)

    OS is defined as the time from the date of first dose to the date of death. For the participants who are alive or lost to follow up, OS is censored as the date of last known alive date or the date of data cutoff, whichever comes first. OS will be calculated using the Kaplan-Meier method.

    Measured: From first dose of study drug until death (up to approximately 5 years)

  6. Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values, Vital Signs, Body Weight and 12-lead Electrocardiograms

    Measured: Baseline up to 28 days after the last dose of study drug (up to approximately 5 years)

  7. Change From Baseline in Oxygen Saturation (SpO2)

    Change from baseline in percent of SpO2 (measured by pulse oximetry) will be calculated by measuring oxygen saturation at rest and immediately after exercise.

    Measured: Baseline up to 28 days after the last dose of study drug (up to approximately 5 years)

  8. Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)

    ECOG PS is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. ECOG has 6 levels (0 to 5). 0=Fully Active (Most Favorable Activity); 1=Restricted activity but ambulatory; 2=Ambulatory but unable to carry out work activities; 3=Limited Self-Care; 4=Completely Disabled, No self-care (Least Favorable Activity); 5=Dead.

    Measured: Baseline, up to approximately 5 years)

  9. Pharmacokinetics (PK) Profiles: Maximum Observed Serum Concentration (Cmax) for Farletuzumab Ecteribulin

    Measured: Up to approximately 5 years

  10. PK Profiles: Time of Cmax (tmax) for Farletuzumab Ecteribulin

    Measured: Up to approximately 5 years

  11. PK Profiles: Area Under the Serum Concentration-time Curve From 0 to Infinity (AUC[0-∞]) for Farletuzumab Ecteribulin

    Measured: Up to approximately 5 years

  12. PK Profiles: Terminal Elimination Phase Half-life (t½) for Farletuzumab Ecteribulin

    Measured: Up to approximately 5 years

  13. Total Antibody Concentration for Eribulin and Farletuzumab Ecteribulin

    Measured: Up to approximately 5 years

  14. Investigate tumor Folate Receptor Alpha (FRA) expression levels association with and predictive power for clinical outcomes (objective response and progression free survival)

    Evaluate how clinical outcomes like objective response and progression free survival correlate with the level of expression of FRA in tumors.

    Measured: Baseline up to 28 days after the last dose of study drug (up to approximately 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2020
  2. Study start6 Aug 2020
  3. Primary completion8 Aug 2030 (estimated)
  4. Study completion8 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
The Part A of Dose Optimization is randomized, whereas the Dose Escalation, Dose Confirmation and Part B of Dose Optimization are non-randomized.
Masking
None (open label)
Enrolment
182 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04300556
Sponsor's protocol ID
MORAb-202-G000-201
Other IDs
2019-003600-12, 2023-506868-14, 2023, 2019
Status last verified
Jun 2026
First submitted
6 Mar 2020
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Publications

  • Wenham RM, Ray-Coquard I, Kristeleit R, Matei D, Ghamande S, Oaknin A, Berek JS, Perez-Fidalgo JA, Sentis PG, Guerra Alia EM, Hou J, Follana P, Eberst L, Clamp A, Frenel JS, Roxburgh P, Jones RH, Pautier P, Jackson AL, Armstrong DK, Song T, Nomoto M, Hawk N, Scott R, Makker V. Farletuzumab ecteribulin, a folate receptor alpha (FRalpha) antibody-drug conjugate, in select advanced cancers: An open-label, multicenter, phase 1/2 dose-finding study. Gynecol Oncol. 2026 Oct 5;213:109-119. doi: 10.1016/j.ygyno.2026.08.023. Online ahead of print.

    PubMed 42833056

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Farletuzumab ecteribulin, Prednisone and Prednisolone in people with Solid Tumor, run by Eisai Inc. at 58 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 55 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, France, Spain, United Kingdom, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eisai Medical Information (1-888-274-2378, esi_oncmedinfo@eisai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Escalation Part: Recommended Phase 2 Dose (RP2D) of Farletuzumab Ecteribulin (time frame: Cycle 1 (Cycle length is equal to [=] 21 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04300556, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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Clinical Trial NCT04300556 | AzTrials