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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 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.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2020-08-06 |
| Est. Completion | 2030-08-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04300556
The ClinicalTrials.gov registry entry for NCT04300556 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (18% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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Related
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