Actively Recruiting
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
Led by Eisai Inc. · Updated on 2026-03-13
182
Participants Needed
58
Research Sites
522 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Females with triple-negative breast cancer, endometrial cancer, or ovarian cancer; males or females with non-small cell lung adenocarcinoma
- Histologically confirmed diagnosis of specified tumor types with relevant disease characteristics
- Platinum-resistant ovarian or related cancers with up to 4 prior systemic therapies
- Advanced, recurrent, or metastatic endometrial cancer with up to 2 prior regimens
- Available tumor tissue for folate receptor alpha expression analysis
- Radiological disease progression after most recent therapy
- Measurable disease by RECIST 1.1 criteria
- ECOG performance status 0 or 1
- Expected survival of at least 3 months after first treatment
- Adequate renal, bone marrow, and liver function
- Required washout periods from prior treatments
- Stable anticoagulation therapy if history of deep vein thrombosis
- Recovery from major surgery and prior treatment toxicities
- Willingness and ability to comply with study procedures
- Written informed consent
- Controlled blood pressure for combination therapy cohorts
You will not qualify if you...
- Diagnosis of endometrial leiomyosarcoma, stromal sarcoma, or other soft tissue sarcoma
- Previous treatment with folate receptor targeting agents except mirvetuximab soravtansine under specific conditions
- Platinum refractory ovarian cancer
- Current participation in other clinical studies or recent investigational drug use
- Brain or subdural metastases unless stable and off corticosteroids
- Meningeal carcinomatosis
- Other invasive malignancies requiring treatment or recent recurrence
- Significant cardiovascular impairment or recent serious cardiac events
- Clinically significant ECG abnormalities or QT prolongation
- Known HIV infection or active viral hepatitis
- Pregnant or breastfeeding females
- Females of childbearing potential not using highly effective contraception
- Males not meeting contraception requirements
- Abnormal pulmonary function tests or lung disease
- Current or suspected interstitial lung disease or pneumonia
- Significant pleural or pericardial effusions or ascites
- Prior pneumonectomy or recent chest radiotherapy
- Autoimmune or inflammatory disorders with lung involvement
- Active tuberculosis
- Scheduled major surgery during study
- Recent serious infections or live vaccine administration
- Hypersensitivity to study drugs or corticosteroids
- Use of prohibited medications
- Psychiatric or substance abuse disorders interfering with study
- For combination therapy: proteinuria, gastrointestinal malabsorption, inability to take oral medication, recent major surgery, serious wounds or fistulas, and major blood vessel invasion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 58 locations
1
ACRC/Arizona Clinical Research Center, Inc
Tucson, Arizona, United States, 85715
Withdrawn
2
Universty of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Completed
3
Stanford Women's Cancer Center
Palo Alto, California, United States, 94304
Actively Recruiting
4
University of Miami
Coral Gables, Florida, United States, 33146
Completed
5
Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Actively Recruiting
6
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Completed
7
Georgia Cancer Center
Augusta, Georgia, United States, 30912
Actively Recruiting
8
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
9
Ascension Illinois-Skokie Infustion Center
Skokie, Illinois, United States, 60077
Withdrawn
10
Norton Healthcare
Louisville, Kentucky, United States, 40202
Withdrawn
11
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
Completed
12
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Completed
13
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Withdrawn
14
MD Anderson Cancer Center at Cooper
Camden, New Jersey, United States, 08103
Completed
15
Columbia University Medical Center
New York, New York, United States, 10032
Completed
16
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
17
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Completed
18
OSU Wxner Medical Center
Hilliard, Ohio, United States, 43026
Withdrawn
19
Oregon Health & Science University
Portland, Oregon, United States, 97239
Withdrawn
20
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Withdrawn
21
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee, United States, 37403
Completed
22
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 07677
Withdrawn
23
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Withdrawn
24
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22903
Completed
25
Centre Antoine Lacassagne Centre R gional de Lutte Contre Le Cancer
Nice, Alpes-Maritimes, France, 06100
Completed
26
ICANS - Institut de canc rologie Strasbourg Europe
Strasbourg, Bas-Rhin, France, 67200
Completed
27
Institut Paoli Calmettes
Marseille, Bouches-du-Rhone, France, 13009
Completed
28
Hopitaux de La Timone
Marseille, Bouches-du-Rhone, France, 13385
Completed
29
Centre Fran ois Baclesse
Caen, Calvados, France, 1400
Completed
30
Clinique Armoricaine de Radiologie-PPDS
Saint-Brieuc, Cote-d'Amore, France, 22000
Withdrawn
31
EDOG Institut de Cancerologie de l Ouest
Nantes, Loir-Atlantique, France, 44000
Completed
32
Clinique Catherine de Sienne
Nantes, Loir-Atlantique, France, 44200
Withdrawn
33
Centre Oscar Lambret
Lille, Nord, France, 59000
Completed
34
Centre Hospitalier de La C te Basque
Bayonne, Pyrenees-Atlantiques, France, 64109
Completed
35
Centre L on B rard Centre R gional de Lutte Contre Le Cancer Rh ne Alpes
Lyone, Rhone, France, 69008
Completed
36
CLCC-Gustave Roussy Cancer
Vilejuif, Val-de-Marne, France, 94805
Completed
37
H pital de la Croix Saint-Simon
Paris, France, 75020
Completed
38
Hopital Cochin
Paris, France, 75679
Completed
39
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 1040045
Actively Recruiting
40
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 1358550
Actively Recruiting
41
ICO Badalona-H.U. Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Actively Recruiting
42
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
43
Hospital General Universitario Gregorio Mara on
Madrid, Spain, 28007
Completed
44
Clinica Universidad de Navarra
Madrid, Spain, 28027
Completed
45
Hospital Clinico San Carlos
Madrid, Spain, 28040
Completed
46
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28304
Completed
47
Hospital Universitario de Toledo
Toledo, Spain, 45007
Completed
48
Fundacion Instituto Valenciano de Oncologia
Valencia, Spain, 46009
Completed
49
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
50
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46013
Completed
51
Belfast City Hospital
Belfast, Antrim, United Kingdom, BT9 7AB
Withdrawn
52
Beatson West of Scotland Cancer Centre-PPDS
Glasgow, Glasgow City, United Kingdom, G12 0YN
Completed
53
The Christie NHS Foundation Trust
Manchester, Lancanshire, United Kingdom, M20 4BX
Completed
54
Lancashire Clinical Research Facility, Royal Preston Hospital
Preston, Lancanshire, United Kingdom, PR2 9HT
Completed
55
Guy's and St Thomas's Hospital
London, London, City of, United Kingdom, SE1 9RT
Completed
56
Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom, HA6 2RN
Completed
57
Velindre Cancer Centre-PPDS
Cardiff, South Glamorgan, United Kingdom, CF14 2TL
Completed
58
The Royal Marsden in Sutton
Sutton, Surrey, United Kingdom, SM2 5PT
Withdrawn
Research Team
E
Eisai Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here