A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRa)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types

Active:	Yes
Cancer Type:	Gynecologic Cancers Lung Cancer Ovarian Cancer Primary Peritoneal Cancer Solid Tumor	NCT ID:	NCT04300556
Trial Phases:	Phase I Phase II	Protocol IDs:	MORAb-202-G000-201 (primary) NCI-2020-06147 2019-003600-12
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Eisai Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT04300556

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).

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