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 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 [EC 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 use of the addition of short course of oral
corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered
every 21 days, as mitigation strategy for interstitial lung disease (ILD); and to select
treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part
B. Part B: to further evaluate the safety, tolerability and preliminary efficacy of 2
treatment regimens with farletuzumab ecteribulin (MORAb-202) in participants with advanced EC
and to determine the recommended treatment regimen for further development of farletuzumab
ecteribulin (MORAb-202).