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Farletuzumab Ecteribulin

Farletuzumab Ecteribulin, also known as MORAb-202, is an innovative drug being studied in clinical trials for the treatment of various solid tumors. This antibody-drug conjugate targets folate receptor alpha (FRα) and is showing potential in treating cancers such as ovarian, endometrial, non-small cell lung, and triple-negative breast cancer. The ongoing trials aim to evaluate its safety, tolerability, and efficacy in patients with these challenging-to-treat cancers.

Table of Contents

What is Farletuzumab Ecteribulin?

Farletuzumab Ecteribulin, also known as MORAb-202, is an innovative drug being studied for the treatment of various solid tumors[1]. It belongs to a class of medications called antibody-drug conjugates (ADCs), which are designed to target and kill cancer cells more precisely than traditional chemotherapy[2].

How Does It Work?

Farletuzumab Ecteribulin works by targeting a specific protein called folate receptor alpha (FRα) that is found on the surface of certain cancer cells[2]. The drug consists of two main components:

  • Farletuzumab: An antibody that specifically binds to FRα on cancer cells
  • Ecteribulin: A potent anti-cancer drug that is attached to the antibody

When Farletuzumab Ecteribulin is administered, the antibody part seeks out and attaches to cancer cells expressing FRα. Once attached, the drug is absorbed by the cancer cell, releasing the ecteribulin component, which then kills the cell[2]. This targeted approach aims to minimize damage to healthy cells and potentially reduce side effects compared to traditional chemotherapy.

What Conditions Does It Treat?

Farletuzumab Ecteribulin is being investigated for the treatment of several types of solid tumors, including[2]:

  • Ovarian cancer (OC): A type of cancer that begins in the ovaries
  • Endometrial cancer (EC): Cancer that starts in the lining of the uterus
  • Non-small cell lung carcinoma (NSCLC): The most common type of lung cancer
  • Triple-negative breast cancer (TNBC): An aggressive form of breast cancer that lacks certain receptors

These cancers often express high levels of FRα, making them potential targets for Farletuzumab Ecteribulin therapy[2].

Clinical Trials and Research

Farletuzumab Ecteribulin is currently being studied in clinical trials to evaluate its safety, efficacy, and optimal dosing. Two main studies are underway:

  1. Phase 1 Study (NCT03386942): This study aims to determine the safety, tolerability, and maximum tolerated dose (MTD) of Farletuzumab Ecteribulin in patients with solid tumors[1].
  2. Phase 1/2 Study (NCT04300556): This larger study is evaluating the safety, tolerability, and efficacy of Farletuzumab Ecteribulin in patients with specific tumor types, including ovarian cancer, endometrial cancer, non-small cell lung cancer, and triple-negative breast cancer[2].

These trials are assessing various aspects of the drug’s performance, including:

  • Objective response rate (ORR): The percentage of patients whose tumors shrink or disappear after treatment
  • Duration of response (DOR): How long the tumor response lasts
  • Progression-free survival (PFS): The time from start of treatment until the cancer progresses or the patient dies
  • Overall survival (OS): The time from start of treatment until death from any cause

Administration and Dosage

Farletuzumab Ecteribulin is administered as an intravenous (IV) infusion, typically once every 3 weeks in a 21-day cycle[1]. The exact dosage and schedule may vary depending on the specific clinical trial and the patient’s response to treatment. Some studies are also exploring different dosing regimens, such as weekly administration or the addition of oral corticosteroids to manage potential side effects[2].

Potential Side Effects

As with any cancer treatment, Farletuzumab Ecteribulin may cause side effects. The clinical trials are closely monitoring for adverse events, including[2]:

  • Interstitial lung disease (ILD): A group of lung disorders that can cause inflammation and scarring
  • Hematological toxicities: Effects on blood cells, such as low white blood cell count (neutropenia) or low platelet count (thrombocytopenia)
  • Infusion reactions: Allergic-like reactions that can occur during or shortly after receiving the drug
  • Other general side effects such as fatigue, nausea, or changes in laboratory values

It’s important to note that the full range of potential side effects is still being studied, and patients in clinical trials are closely monitored for any adverse reactions.

Future Prospects

The ongoing clinical trials will help determine the effectiveness and safety profile of Farletuzumab Ecteribulin. If the results are promising, this drug could potentially offer a new treatment option for patients with certain types of solid tumors, particularly those that have not responded well to other therapies[2].

Researchers are also investigating whether the levels of folate receptor alpha (FRα) in tumors can predict how well a patient might respond to Farletuzumab Ecteribulin. This could help identify which patients are most likely to benefit from this treatment in the future[2].

Aspect Details
Drug Name Farletuzumab Ecteribulin (MORAb-202)
Drug Type Antibody-drug conjugate targeting folate receptor alpha (FRα)
Administration Intravenous infusion
Target Cancers Solid tumors, including ovarian, endometrial, non-small cell lung, and triple-negative breast cancer
Trial Phases Phase 1 and Phase 2
Primary Objectives Evaluate safety, tolerability, determine recommended dose, assess preliminary efficacy
Key Outcome Measures Objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), overall survival (OS)
Safety Monitoring Adverse events, laboratory values, vital signs, electrocardiograms, special focus on interstitial lung disease (ILD)
Dosing Strategy Various schedules explored, typically every 3 weeks in 21-day cycles

FAQ

  • What is Farletuzumab Ecteribulin? Farletuzumab Ecteribulin, also called MORAb-202, is an antibody-drug conjugate that targets folate receptor alpha (FRα). It is being studied as a potential treatment for various solid tumors, including ovarian, endometrial, non-small cell lung, and triple-negative breast cancer.
  • How is Farletuzumab Ecteribulin administered? Farletuzumab Ecteribulin is administered as an intravenous (IV) infusion. The dosing schedule varies depending on the specific trial and treatment phase, but it is typically given every 3 weeks in a 21-day cycle.
  • What are the main objectives of the clinical trials studying Farletuzumab Ecteribulin? The main objectives of these trials are to evaluate the safety and tolerability of the drug, determine the recommended dose for future studies, and assess its preliminary efficacy in treating various solid tumors. The trials also aim to measure outcomes such as objective response rate, duration of response, and progression-free survival.
  • What are some of the side effects being monitored in these trials? The trials are closely monitoring for adverse events, including serious adverse events and those leading to treatment discontinuation. Special attention is given to interstitial lung disease (ILD) and other adverse events of interest. The studies also track changes in laboratory values, vital signs, and electrocardiograms.
  • How is the effectiveness of Farletuzumab Ecteribulin measured in these trials? The effectiveness is measured through various outcomes, including objective response rate (ORR), duration of response (DOR), disease control rate (DCR), clinical benefit rate (CBR), progression-free survival (PFS), and overall survival (OS). These measures help researchers understand how well the drug works in shrinking tumors and improving patient outcomes.

Ongoing Clinical Trials on Farletuzumab Ecteribulin

  • Study on the Safety and Effects of Farletuzumab Ecteribulin for Patients with Ovarian, Breast, Endometrial, and Lung Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Spain

  • Study of Farletuzumab Ecteribulin vs. Chemotherapy for Women with Platinum-resistant High-grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Italy Spain

  • Study of Farletuzumab Ecteribulin for Patients with Metastatic Non-Small Cell Lung Cancer After Previous Treatments

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Spain

Glossary

  • Antibody-drug conjugate (ADC): A type of targeted cancer therapy that combines a monoclonal antibody with a potent anti-cancer drug. The antibody helps deliver the drug directly to cancer cells, potentially reducing side effects on healthy cells.
  • Folate receptor alpha (FRα): A protein found in high levels on the surface of some cancer cells. It is the target of Farletuzumab Ecteribulin.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dosage or require a decrease in dosage.
  • Maximum tolerated dose (MTD): The highest dose of a drug that does not cause unacceptable side effects.
  • Recommended Phase 2 dose (RP2D): The dose of a drug determined to be appropriate for further testing in Phase 2 clinical trials.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall survival (OS): The length of time from the start of treatment that patients are still alive.
  • RECIST: Response Evaluation Criteria In Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Interstitial lung disease (ILD): A group of disorders that cause inflammation and scarring in the lungs, which can be a potential side effect of some cancer treatments.

References