Recruiting

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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying certain types of cancer, specifically platinum-resistant ovarian cancer, triple-negative breast cancer (TNBC), endometrial cancer (EC), and non-small cell lung cancer (NSCLC). The treatment being tested is called farletuzumab ecteribulin, also known by its code name MORAb-202. This treatment is a special type of medication known as an antibody-drug conjugate (ADC), which is designed to target cancer cells more precisely.

The purpose of the study is to evaluate the safety and effectiveness of MORAb-202 in patients with these specific types of cancer. The study will be conducted in different phases. Initially, the focus will be on determining the safest dose of the medication. Following this, the study will further assess how well the treatment works in patients with ovarian cancer and endometrial cancer. The study will also explore different treatment schedules to find the most effective approach for patients with advanced endometrial cancer.

Participants in the study will receive the treatment through an intravenous infusion, which means the medication will be administered directly into the bloodstream. The study will monitor participants for any side effects and measure how the cancer responds to the treatment. The goal is to gather information that could lead to the development of a new treatment option for these types of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will undergo a washout period. This is a time when previous treatments are stopped to ensure they do not interfere with the study drug.
The patient must have recovered from any side effects of previous treatments to a mild level, except for certain conditions like stable sensory neuropathy, mild anemia, and hair loss.
Step 2
Initial assessment
The patient will provide a sample of tumor tissue for analysis. This is to check for the presence of a specific protein called folate receptor alpha.
A series of tests will be conducted to confirm the patient's health status, including blood tests, imaging studies, and assessments of heart and lung function.
Step 3
Dose-escalation phase
The patient will receive the study drug, MORAb-202, through an intravenous infusion. The dose will be gradually increased to determine the safest and most effective dose.
The patient's response to the drug will be closely monitored, including any side effects and changes in tumor size.
Step 4
Dose-confirmation phase
Once the optimal dose is identified, the patient will continue to receive the study drug at this dose.
The focus will be on evaluating the drug's safety and effectiveness in reducing tumor size.
Step 5
Dose-optimization phase
In this phase, different treatment schedules of the study drug will be tested to find the best regimen.
The patient will be monitored for safety and any changes in their condition.
Step 6
Follow-up
After completing the treatment phases, the patient will have regular follow-up visits to monitor their health and any long-term effects of the study drug.
These visits will include physical exams, imaging studies, and laboratory tests.

Who can join the trial?

21 criteria

Must be at least 18 years old.
For the initial part of the study:
- Females with triple-negative breast cancer (TNBC), endometrial cancer (EC), or ovarian cancer (OC), or males and females with non-small cell lung cancer (NSCLC) adenocarcinoma.
- TNBC: Must have a confirmed diagnosis of metastatic TNBC, which means the cancer has spread to other parts of the body. The cancer must be negative for certain receptors (ER, PR, HER2). Must have had at least one previous treatment for cancer that has spread.
- NSCLC adenocarcinoma: Must have a confirmed diagnosis of metastatic NSCLC adenocarcinoma. Must have tried previous treatments that did not work, and no other standard treatments are available.
- EC: Must have a confirmed diagnosis of advanced, recurrent, or metastatic EC. Must have tried at least one treatment with platinum-based drugs or immunotherapy that did not work.
- Ovarian cancer or related cancers: Must have a confirmed diagnosis of high-grade serous epithelial OC or related cancers. The cancer must be resistant to platinum-based treatments, meaning it worsened within 6 months after the last treatment. Must have had up to 4 different treatments after developing resistance.
- Must have available tumor tissue for testing a specific protein (FRA) in a lab.
- Must show disease progression on scans after the most recent treatment.
- Must have measurable disease as described in the study protocol.
- Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, which means being fully active or having some symptoms but being able to carry out light work.
- Must be expected to live at least 3 months after starting the study drug.
- Must have adequate kidney function as defined in the study protocol.
- Must have adequate bone marrow function as defined in the study protocol.
- Must have adequate liver function as defined in the study protocol.
- Must have a break period from previous treatments before starting the study drug.
- If there is a history of deep vein thrombosis (DVT) within 3 months, must be on a stable dose of blood thinners for at least 2 weeks before starting the study and continue while on the study.
- If at risk for DVT, must have a test (venous Doppler ultrasonography) to rule out DVT before starting the study.
- If major surgery was done, must have recovered from any side effects or complications before starting the study.
- Must have resolved any side effects from previous cancer treatments to a mild level, except for stable mild nerve damage, mild anemia, and hair loss.
- Must be willing and able to follow all study requirements.
- Must provide written consent before any study-specific procedures.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer than the ones being studied, which are specific types of ovarian, breast, endometrial, and lung cancer.
Patients who are not within the age range specified for the study.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have other serious health conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding, as the study medication might affect the baby.
Patients who are currently participating in another clinical trial or have recently participated in one.
Patients who have had a recent major surgery or are planning to have surgery during the study period.
Patients who have a history of allergic reactions to similar medications or any of the ingredients in the study medication.
Patients who have certain infections that are not well controlled, as these might affect the study results or the patient's safety.
Patients who have a history of drug or alcohol abuse, which might interfere with their ability to follow the study requirements.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Assistance Publique Hopitaux De Marseille
Marseille, France
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Centre Francois Baclesse
Caen, France
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Centre Hospitalier De La Cote Basque
Bayonne, France

Trial locations

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Investigated drugs

MORAb-202 is an investigational medication being studied in this clinical trial. It is a type of treatment known as an antibody-drug conjugate (ADC). This means it combines an antibody, which can specifically target certain cells, with a drug that can kill those cells. In this trial, MORAb-202 is designed to target a protein called folate receptor alpha (FRα) that is often found on the surface of certain cancer cells. The goal of this treatment is to deliver the drug directly to the cancer cells, potentially reducing harm to normal cells and improving the effectiveness of the treatment. The trial is focused on evaluating the safety, tolerability, and effectiveness of MORAb-202 in patients with specific types of tumors, including ovarian cancer, endometrial cancer, non-small cell lung cancer, and triple-negative breast cancer.

What is already known about the treatment

MORAb-202 – This medication is administered intravenously and is currently being studied in clinical trials for its safety, tolerability, and effectiveness. It is primarily being investigated for use in treating solid tumors, specifically in cases of platinum-resistant ovarian cancer, triple-negative breast cancer, endometrial cancer, and non-small cell lung cancer adenocarcinoma. MORAb-202 works by targeting the folate receptor alpha, which is often overexpressed in these types of cancer cells, allowing the drug to deliver a cytotoxic agent directly to the tumor. It is classified as an antibody-drug conjugate, a type of targeted cancer therapy designed to minimize damage to healthy cells while effectively attacking cancerous ones.

Investigated diseases

Platinum-Resistant Ovarian Cancer
This type of ovarian cancer does not respond to platinum-based chemotherapy, which is a common treatment for ovarian cancer. It typically progresses despite treatment, leading to the need for alternative therapeutic strategies. The cancer cells continue to grow and spread, often resulting in the need for more aggressive or different treatment approaches.
Triple-Negative Breast Cancer (TNBC)
This is a subtype of breast cancer that lacks three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. TNBC tends to grow and spread more quickly than other types of breast cancer. It is often diagnosed at a more advanced stage and can be more challenging to treat due to the lack of targeted therapies.
Endometrial Cancer (EC)
This cancer begins in the lining of the uterus, known as the endometrium. It is the most common type of uterine cancer and often presents with symptoms like abnormal vaginal bleeding. The disease can progress by invading the uterine wall and potentially spreading to other parts of the body if not detected early.
Non-Small Cell Lung Cancer Adenocarcinoma (NSCLC)
This is the most common type of lung cancer, accounting for about 85% of cases. Adenocarcinoma is a subtype that typically starts in the mucus-secreting glands of the lung. It tends to grow more slowly than other types of lung cancer, but it can spread to other parts of the body if not treated.