Farletuzumab ecteribulin
DrugFarletuzumab ecteribulin intravenous infusion.
Other names: MORAb-202
NCT Number: NCT04300556
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer, Nice, Alpes-Maritimes, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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:
Endometrial cancer (not enrolled in Dose Optimization Part B):
For Dose Optimization Part B, adequate renal function as evidenced by calculated creatinine clearance >=50 milliliters per minute (mL/min) by Cockcroft-Gault formula.
Prior anticancer therapy:
Exclusion criteria
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.
For participants enrolled in the MORAb-202 plus lenvatinib cohorts, prolongation of the QTcF interval to >480 ms.
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.
Dose Optimization Part B participants who receiving MORAb-202 in combination with lenvatinib:
Farletuzumab ecteribulin intravenous infusion.
Other names: MORAb-202
Prednisone administered orally.
Prednisolone administered orally.
Dexamethasone administered orally.
Lenvatinib administered orally.
Time frame: Cycle 1 (Cycle length is equal to [=] 21 days)
Time frame: Up to approximately 5 years
Time frame: From date of first dose of study drug until first documentation of CR or PR (up to approximately 24 weeks)
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: Cycle 1 (Cycle length=21 days)
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: Baseline up to 28 days after the last dose of study drug (up to approximately 5 years)
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: From first documented CR or PR until first documentation of recurrent or progressive disease or death (up to approximately 5 years)
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 dose of study drug until first documentation of CR or PR or SD (up to approximately 5 years)
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 disease progression or death, whichever occurs first (up to approximately 5 years)
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, death, whichever occurs first (up to approximately 5 years)
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 death (up to approximately 5 years)
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: Baseline up to 28 days after the last dose of study drug (up to approximately 5 years)
Time frame: Baseline up to 28 days after the last dose of study drug (up to approximately 5 years)
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 approximately 5 years)
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: Up to approximately 5 years
Time frame: Up to approximately 5 years
Time frame: Up to approximately 5 years
Time frame: Up to approximately 5 years
Time frame: Up to approximately 5 years
Time frame: Baseline up to 28 days after the last dose of study drug (up to approximately 5 years)
Evaluate how clinical outcomes like objective response and progression free survival correlate with the level of expression of FRA in tumors.
Contact information is provided by the study sponsor or research team.
Eisai Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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