RecruitingPhase 1Phase 2NCT04300556

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 Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types

Sponsor

Eisai Inc.

Enrollment

182 participants

Start Date

Aug 6, 2020

Study Type

INTERVENTIONAL

Conditions

Solid Tumor

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of targeted cancer drug called farletuzumab ecteribulin (MORAb-202) — a drug that homes in on a protein called folate receptor alpha found on the surface of certain cancer cells and delivers a cell-killing payload directly to them. **You may be eligible if...** - You are at least 18 years old - You have advanced, previously treated triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), ovarian cancer (OC), or endometrial cancer (EC) - Your tumor type has been confirmed by biopsy - You have already received at least one prior systemic treatment for your cancer - You have measurable disease on imaging **You may NOT be eligible if...** - You have untreated brain metastases - Your heart, kidney, or liver function is significantly impaired - You are pregnant or breastfeeding - You have active, uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFarletuzumab ecteribulin

Farletuzumab ecteribulin intravenous infusion.

DRUGPrednisone

Prednisone administered orally.

DRUGPrednisolone

Prednisolone administered orally.

DRUGDexamethasone

Dexamethasone administered orally.

DRUGLenvatinib

Lenvatinib administered orally.

Locations(58)

ACRC/Arizona Clinical Research Center, Inc

Tucson, Arizona, United States

Universty of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Stanford Women's Cancer Center

Palo Alto, California, United States

University of Miami

Coral Gables, Florida, United States

Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Winship Cancer Institute

Atlanta, Georgia, United States

Georgia Cancer Center

Augusta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Ascension Illinois-Skokie Infustion Center

Skokie, Illinois, United States

Norton Healthcare

Louisville, Kentucky, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

MD Anderson Cancer Center at Cooper

Camden, New Jersey, United States

Columbia University Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

OSU Wxner Medical Center

Hilliard, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Chattanooga's Program in Women's Oncology

Chattanooga, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, United States

Centre Antoine Lacassagne Centre R gional de Lutte Contre Le Cancer

Nice, Alpes-Maritimes, France

ICANS - Institut de canc rologie Strasbourg Europe

Strasbourg, Bas-Rhin, France

Institut Paoli Calmettes

Marseille, Bouches-du-Rhone, France

Hopitaux de La Timone

Marseille, Bouches-du-Rhone, France

Centre Fran ois Baclesse

Caen, Calvados, France

Clinique Armoricaine de Radiologie-PPDS

Saint-Brieuc, Cote-d'Amore, France

EDOG Institut de Cancerologie de l Ouest

Nantes, Loir-Atlantique, France

Clinique Catherine de Sienne

Nantes, Loir-Atlantique, France

Centre Oscar Lambret

Lille, Nord, France

Centre Hospitalier de La C te Basque

Bayonne, Pyrenees-Atlantiques, France

Centre L on B rard Centre R gional de Lutte Contre Le Cancer Rh ne Alpes

Lyone, Rhone, France

CLCC-Gustave Roussy Cancer

Vilejuif, Val-de-Marne, France

H pital de la Croix Saint-Simon

Paris, France

Hopital Cochin

Paris, France

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

ICO Badalona-H.U. Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital General Universitario Gregorio Mara on

Madrid, Spain

Clinica Universidad de Navarra

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario de Toledo

Toledo, Spain

Fundacion Instituto Valenciano de Oncologia

Valencia, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

Belfast City Hospital

Belfast, Antrim, United Kingdom

Beatson West of Scotland Cancer Centre-PPDS

Glasgow, Glasgow City, United Kingdom

The Christie NHS Foundation Trust

Manchester, Lancanshire, United Kingdom

Lancashire Clinical Research Facility, Royal Preston Hospital

Preston, Lancanshire, United Kingdom

Guy's and St Thomas's Hospital

London, London, City of, United Kingdom

Mount Vernon Cancer Centre

Northwood, Middlesex, United Kingdom

Velindre Cancer Centre-PPDS

Cardiff, South Glamorgan, United Kingdom

The Royal Marsden in Sutton

Sutton, Surrey, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04300556

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