A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types
← catalyst calendarNCT04300556 · readout in 1,450 d
Sponsored by Eisai Inc. (industry) · 4523.T — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
182estimated
Sites
58
Countries
France, Japan, Spain +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-08-06 | actual | When the study began enrolling |
| Primary completion | 2030-08-08 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-08-08 | estimated | The whole study's end, after follow-up |
| First posted | 2020-03-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Solid Tumor
Interventions
- Drug: Farletuzumab ecteribulin — also filed as MORAb-202
- Drug: Prednisone
- Drug: Prednisolone
- Drug: Dexamethasone
- Drug: Lenvatinib
Primary outcomes
what the primary-completion date above is the date OFDose Escalation Part: Recommended Phase 2 Dose (RP2D) of Farletuzumab Ecteribulin
measured Cycle 1 (Cycle length is equal to [=] 21 days)
Dose Optimization Part B: Recommended Dose (RD) of Farletuzumab Ecteribulin Monotherapy and in Combination With Lenvatinib
measured Up to approximately 5 years
Objective Response Rate (ORR)
measured From date of first dose of study drug until first documentation of CR or PR (up to approximately 24 weeks)
Number of Participants With Dose-limiting Toxicities (DLTs)
measured Cycle 1 (Cycle length=21 days)
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Treatment Discontinuation and Adverse Events of Interest (AEIs)
measured Baseline up to 28 days after the last dose of study drug (up to approximately 5 years)
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