A Phase 1/2 interventional study of Farletuzumab ecteribulin and Prednisone in Solid Tumor, sponsored by Eisai Inc.. Recruiting at 58 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Eisai Inc. · Phase 1/2, Interventional, and Treatment
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.
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:
Participants must have:
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:
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
Endometrial cancer (not enrolled in Dose Optimization Part B):
Measurable disease meeting the following criteria (confirmed by central radiographic review, in the Dose-Confirmation Part only):
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:
Adequate liver function, as evidenced by:
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:
Exclusion Criteria:
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.
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:
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.
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:
Participants with selected tumor types will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once every 3 weeks in a 21-day cycle.
Drug: Farletuzumab ecteribulin
Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion, once every 3 weeks in a 21-day cycle.
Drug: Farletuzumab ecteribulin
Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion and oral corticosteroids in a 21-day cycle.
Drug: Farletuzumab ecteribulin · Drug: Prednisone · Drug: Prednisolone · Drug: Dexamethasone
Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion on three different days in a 21-day cycle.
Drug: Farletuzumab ecteribulin
Participants with EC and OC will receive farletuzumab ecteribulin (MORAb-202) as an intravenous infusion on two different days in a 21-day cycle.
Drug: Farletuzumab ecteribulin
Participants 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.
Drug: Farletuzumab ecteribulin · Drug: Lenvatinib
Farletuzumab ecteribulin intravenous infusion.
Also known as: MORAb-202
Prednisone administered orally.
Prednisolone administered orally.
Dexamethasone administered orally.
Lenvatinib administered orally.
Dose Escalation Part: Recommended Phase 2 Dose (RP2D) of Farletuzumab Ecteribulin
Time frame: Cycle 1 (Cycle length is equal to [=] 21 days)
Dose Optimization Part B: Recommended Dose (RD) of Farletuzumab Ecteribulin Monotherapy and in Combination With Lenvatinib
Time frame: Up to approximately 5 years
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.
Time frame: From date of first dose of study drug until first documentation of CR or PR (up to approximately 24 weeks)
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).
Time frame: Cycle 1 (Cycle length=21 days)
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.
Time frame: Baseline up to 28 days after the last dose of study drug (up to approximately 5 years)
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.
Time frame: From first documented CR or PR until first documentation of recurrent or progressive disease or death (up to approximately 5 years)
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.
Time frame: From first dose of study drug until first documentation of CR or PR or SD (up to approximately 5 years)
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.
Time frame: From first dose of study drug until disease progression or death, whichever occurs first (up to approximately 5 years)
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.
Time frame: From first dose of study drug until disease progression, death, whichever occurs first (up to approximately 5 years)
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.
Time frame: From first dose of study drug until death (up to approximately 5 years)
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values, Vital Signs, Body Weight and 12-lead Electrocardiograms
Time frame: Baseline up to 28 days after the last dose of study drug (up to approximately 5 years)
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.
Time frame: Baseline up to 28 days after the last dose of study drug (up to approximately 5 years)
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.
Time frame: Baseline, up to approximately 5 years)
Pharmacokinetics (PK) Profiles: Maximum Observed Serum Concentration (Cmax) for Farletuzumab Ecteribulin
Time frame: Up to approximately 5 years
PK Profiles: Time of Cmax (tmax) for Farletuzumab Ecteribulin
Time frame: Up to approximately 5 years
PK Profiles: Area Under the Serum Concentration-time Curve From 0 to Infinity (AUC[0-∞]) for Farletuzumab Ecteribulin
Time frame: Up to approximately 5 years
PK Profiles: Terminal Elimination Phase Half-life (t½) for Farletuzumab Ecteribulin
Time frame: Up to approximately 5 years
Total Antibody Concentration for Eribulin and Farletuzumab Ecteribulin
Time frame: Up to approximately 5 years
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.
Time frame: Baseline up to 28 days after the last dose of study drug (up to approximately 5 years)
Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Eisai Inc.