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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: Lung 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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