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NCT04300556 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Solid Tumor, sponsored by Eisai.

Recruiting
Registry status
Phase 1
Development phase
182
Enrollment target
20
Study locations

NCT04300556: Recruiting Phase 1 study of Solid Tumor, sponsored by Eisai.

NCT04300556 is a Phase 1 study of Solid Tumor that is actively recruiting participants, run by Eisai. The registered enrollment target is 182 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04300556, a Phase 1 study of Solid Tumor, is actively recruiting participants, sponsored by Eisai.

RECRUITING
Registry status
Phase 1
Development phase
182 participants
Enrollment target
20
Study locations

Study 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 \[OC only\]): 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.

Conditions Studied

Solid Tumor

Interventions

  • DRUG Dexamethasone
  • DRUG Prednisone
  • DRUG Prednisolone
  • DRUG Lenvatinib
  • DRUG Farletuzumab ecteribulin

Study Locations (20)

Florida

  • University of Miami - Coral Gables
  • Moffitt Cancer Center and Research Institute - Tampa

Georgia

  • Winship Cancer Institute - Atlanta
  • Georgia Cancer Center - Augusta

Illinois

  • Northwestern Memorial Hospital - Chicago
  • Ascension Illinois-Skokie Infustion Center - Skokie

Michigan

  • Karmanos Cancer Institute - Detroit
  • Henry Ford Hospital - Detroit

New York

  • Columbia University Medical Center - New York
  • Memorial Sloan Kettering Cancer Center - New York

Ohio

  • University of Cincinnati Medical Center - Cincinnati
  • OSU Wxner Medical Center - Hilliard

Arizona

  • ACRC/Arizona Clinical Research Center, Inc - Tucson

Arkansas

  • Universty of Arkansas for Medical Sciences - Little Rock

Trial Details

FieldValue
Enrollment Target 182 participants
Start Date 2020-08-06
Est. Completion 2030-08-08
Phase Phase 1
Eisai

287 total trials

What NCT04300556 shows while recruiting

NCT04300556 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (18% lower).

The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 5 interventions - of which Dexamethasone is the first listed.

NCT04300556 names 20 study sites across 14 states, led by Florida, Georgia, Illinois.

Frequently Asked Questions

What is clinical trial NCT04300556 about?

NCT04300556 is a clinical study titled "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". 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-...

What is the current status of trial NCT04300556?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 182 participants. The study started on 2020-08-06. Estimated completion is 2030-08-08.

What conditions does trial NCT04300556 study?

This clinical trial studies the following conditions: Solid Tumor.

What interventions are being tested in trial NCT04300556?

The interventions under investigation include: Dexamethasone (DRUG), Prednisone (DRUG), Prednisolone (DRUG), Lenvatinib (DRUG), Farletuzumab ecteribulin (DRUG).

Who is sponsoring clinical trial NCT04300556?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04300556 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04300556's enrollment target sits among peer trials

182 45th of 196 higher than 151 of 196 other Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04300556

Source: ClinicalTrials.gov NCT04300556, the US trial registry maintained by the National Library of Medicine. NCT04300556 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.