RecruitingPHASE1, PHASE2INTERVENTIONAL

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

This research study is looking at a new treatment called Farletuzumab Ecteribulin for people with certain advanced cancers, including ovarian, endometrial, a type of breast cancer (triple-negative), and a type of lung cancer (non-small cell lung carcinoma). The main goals are to understand how safe the new drug is, what side effects it might cause, and to find the most effective dose. The study also aims to see how well the drug shrinks tumours or stops them from growing, both on its own and when combined with another treatment called Lenvatinib. Some parts of the study will also explore if taking steroid medications like Prednisone or Dexamethasone with the new drug helps manage any side effects. This involves different steps, from testing initial doses to fine-tuning the treatment plan.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Eisai Inc.

Enrolment target

182

Start

06 Aug 2020

Estimated completion

08 Aug 2030

Solid Tumor

What is this study about?

This research study is investigating a new medication called Farletuzumab Ecteribulin. This drug is designed to target specific cancer cells that have a protein called Folate Receptor Alpha (FRα) on their surface. It's like a guided missile, aiming to deliver treatment directly to the cancer while trying to spare healthy cells. We're looking at this new treatment for several types of advanced cancers, including certain forms of ovarian cancer, endometrial cancer, triple-negative breast cancer, and a type of lung cancer called non-small cell lung carcinoma.

The main purpose of this study is to gather important information about Farletuzumab Ecteribulin. We want to understand how safe it is for people, what kinds of side effects it might cause, and to figure out the best dose to use. We'll also be carefully checking to see if the drug helps to shrink tumours or stops them from growing. This study is divided into different stages, moving from testing small groups of people to find the right dose, to then exploring how well it works and optimising how it's given.

In some parts of the study, we'll also be looking at whether giving steroid medications, such as Prednisone or Dexamethasone, alongside Farletuzumab Ecteribulin can help manage any potential side effects. We'll also investigate combining Farletuzumab Ecteribulin with another existing cancer drug called Lenvatinib, to see if this combination could be more effective. This careful step-by-step approach helps us to thoroughly understand this new treatment.

Key takeaways

This study is testing a new drug for advanced cancers like ovarian, endometrial, and some breast and lung cancers.
The main goals are to assess safety, find the best dose, and see how effective the new treatment is.
Other medications, including steroids or Lenvatinib, might be used alongside the new drug.
Participants must be at least 18 years old and have certain types of cancer that have progressed after previous treatments.
Participation involves regular hospital visits for assessments and monitoring.
There are potential benefits and risks, and you can withdraw from the study anytime.

Who may be eligible?

To join this study, participants must be at least 18 years old. People of all genders can take part.

For most parts of the study, you would need to have certain types of advanced cancer that have either spread or come back after previous treatment. This includes specific kinds of ovarian cancer, endometrial cancer, a type of breast cancer called triple-negative breast cancer, and a type of lung cancer called non-small cell lung carcinoma. Generally, your cancer must have either progressed after or not responded well to standard treatments that are usually given.

More specifically, if you have triple-negative breast cancer, you would have already received at least one course of treatment for your advanced cancer. If you have non-small cell lung cancer, you would have tried previous treatments for advanced disease and your cancer would not be suitable for or responded to certain targeted therapies. For endometrial cancer, you would have received at least one platinum-based or immunotherapy-based treatment that did not work or stopped working. If you have ovarian, primary peritoneal, or fallopian tube cancer, your cancer must have returned within 6 months of finishing platinum-based chemotherapy and you would have received up to four lines of treatment since your cancer became platinum-resistant.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years of age or older?
Do you have advanced ovarian, endometrial, triple-negative breast, or a specific type of lung cancer?
Has your cancer progressed or come back after previous standard treatments?
Are you able to attend regular hospital visits and undergo medical tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medication, Farletuzumab Ecteribulin, which might be given on its own or in combination with other approved medications like corticosteroids (Prednisone, Prednisolone, Dexamethasone) or Lenvatinib. The specific treatment plan, including how often you receive the medication, will depend on which part of the study you are in. You will have regular visits to the hospital or clinic for assessments, which will include blood tests, physical examinations, and scans to monitor your health and how the treatment is affecting your cancer. The total duration of your participation will vary, but you will continue treatment for as long as it is helping and you are tolerating it well, or until the study doctor decides to stop it. There will also be a follow-up period after your last dose of study medication to monitor your health.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing new and experimental treatments that are not yet widely available. While we hope this new drug will be effective, there's no guarantee it will work for everyone, and it might not be better than existing treatments. Like all medications, Farletuzumab Ecteribulin may cause side effects, some of which could be serious or unexpected. The research team will explain all known side effects. Your safety is our top priority, and you will be carefully monitored throughout the study. You always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (58)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

ACRC/Arizona Clinical Research Center, Inc
Verified postcode
Tucson, United States· Withdrawn
Universty of Arkansas for Medical Sciences
Verified postcode
Little Rock, United States· Completed
Stanford Women's Cancer Center
Verified postcode
Palo Alto, United States· Recruiting
University of Miami
Verified postcode
Coral Gables, United States· Completed
Moffitt Cancer Center and Research Institute
Verified postcode
Tampa, United States· Recruiting
Winship Cancer Institute
Verified postcode
Atlanta, United States· Completed
Georgia Cancer Center
Verified postcode
Augusta, United States· Recruiting
Northwestern Memorial Hospital
Verified postcode
Chicago, United States· Recruiting
Ascension Illinois-Skokie Infustion Center
Verified postcode
Skokie, United States· Withdrawn
Norton Healthcare
Verified postcode
Louisville, United States· Withdrawn
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verified postcode
Baltimore, United States· Completed
Karmanos Cancer Institute
Verified postcode
Detroit, United States· Completed

Common questions

What is Farletuzumab Ecteribulin?

It's a new investigational drug designed to target specific cancer cells that have a protein called Folate Receptor Alpha (FRα) on their surface.

Which cancers is this study for?

This study is for advanced ovarian, endometrial, triple-negative breast, and non-small cell lung cancers that have progressed after standard treatments.

What is a 'Phase 1/2' study?

Phase 1 studies primarily check if a new drug is safe and help find the right dose. Phase 2 studies then look at how well the drug works at that dose.

Will I receive other medications in this study?

Yes, depending on the study part, you might receive corticosteroids (like Prednisone) or another cancer drug called Lenvatinib alongside Farletuzumab Ecteribulin.

Can I leave the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Eisai Medical Information

esi_oncmedinfo@eisai.com 1-888-274-2378 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.