Condition: Solid Tumor · Sponsor: Eisai Inc.
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.
This description comes directly from the study's public registry record.
Eisai Medical Information · 1-888-274-2378 · esi_oncmedinfo@eisai.com
Always discuss trial participation with your own doctor first.
| ACRC/Arizona Clinical Research Center, Inc | Tucson, Arizona, United States | Withdrawn |
| Universty of Arkansas for Medical Sciences | Little Rock, Arkansas, United States | Completed |
| Stanford Women's Cancer Center | Palo Alto, California, United States | Recruiting |
| University of Miami | Coral Gables, Florida, United States | Completed |
| Moffitt Cancer Center and Research Institute | Tampa, Florida, United States | Recruiting |
| Winship Cancer Institute | Atlanta, Georgia, United States | Completed |
| Georgia Cancer Center | Augusta, Georgia, United States | Recruiting |
| Northwestern Memorial Hospital | Chicago, Illinois, United States | Recruiting |
| Ascension Illinois-Skokie Infustion Center | Skokie, Illinois, United States | Withdrawn |
| Norton Healthcare | Louisville, Kentucky, United States | Withdrawn |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland, United States | Completed |
| Karmanos Cancer Institute | Detroit, Michigan, United States | Completed |
+ 46 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04300556