Study on the Safety and Effectiveness of IMGN151 for Women with Recurrent Endometrial and Ovarian Cancer

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What is this study about?

This clinical trial is focused on studying the safety and effectiveness of a new treatment called IMGN151 for women with certain types of cancer that have returned after treatment. The cancers being studied include recurrent endometrial cancer and recurrent high-grade serous epithelial ovarian cancer, as well as similar cancers affecting the lining of the abdomen and fallopian tubes. IMGN151 is a special type of medication known as an antibody-drug conjugate, which is designed to target and attack cancer cells more precisely.

The purpose of the study is to determine the best dose of IMGN151 that can be safely given to patients and to see how well it works in treating these cancers. The study will be conducted in two main phases. In the first phase, different doses of IMGN151 will be tested to find the safest and most effective dose. In the second phase, the chosen dose will be given to more patients to further assess its effectiveness. Throughout the study, participants will receive IMGN151 through an intravenous infusion, which means the medication will be delivered directly into the bloodstream through a vein.

Participants in the study will be closely monitored for any side effects and to see how their cancer responds to the treatment. The study aims to provide valuable information about the potential benefits and risks of IMGN151 for women with these specific types of recurrent cancers. This research is important for developing new treatment options that could improve outcomes for patients facing these challenging conditions.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures. The patient must sign an informed consent form to confirm understanding and agreement to participate.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, current health status, and any previous treatments. Blood tests and imaging may be conducted to ensure the patient meets the study criteria.

3 dose-escalation phase

During this phase, the patient will receive IMGN151 intravenously. The purpose is to determine the safest and most effective dose. The patient will be monitored for any side effects or adverse reactions. The frequency and dosage will be adjusted based on the patient’s response.

4 expansion phase

In this phase, the patient will continue to receive IMGN151 at the determined dose. The focus is on evaluating the treatment’s effectiveness in reducing cancer size or progression. Regular assessments will be conducted to monitor the patient’s condition.

5 use of eye drops

The patient will use Pred Forte 1% w/v Eye Drops Suspension and Brimonidine Tartrate 0.2% w/v Eye Drops for conjunctival use. These medications are administered as eye drops to manage any ocular symptoms or side effects. The frequency and duration will be specified by the healthcare provider.

6 ongoing monitoring

Throughout the trial, the patient will have regular check-ups to monitor health status and treatment effects. This includes blood tests, imaging, and other necessary evaluations to ensure safety and effectiveness.

7 completion of the trial

Upon completion of the trial, the patient will undergo a final assessment. This will include a comprehensive review of the treatment’s impact on the patient’s condition and any long-term effects. The patient will receive guidance on post-trial care and follow-up.

Who Can Join the Study?

Patients must be at least 18 years old.
Must have completed any major surgery at least 4 weeks before the first dose of the study drug and have recovered or stabilized from the side effects of prior surgery.
Must have adequate blood, liver, and kidney functions. This means:
- Enough white blood cells without recent use of growth factors.
- Enough platelets without recent transfusion.
- Enough hemoglobin without recent blood transfusion.
- Good kidney function.
- Liver enzymes within acceptable limits.
- Normal bilirubin levels, with some exceptions for certain conditions.
- Enough albumin in the blood.
Must be willing and able to sign a consent form and follow the study requirements.
Women who can have children must agree to use effective birth control during the study and for at least 28 weeks after the last dose.
Women who can have children must have a negative pregnancy test before starting the study drug.
Must have a performance status of 0 or 1, which means being fully active or having some restrictions but able to carry out light work.
For the Dose-Escalation Phase, must have a confirmed diagnosis of certain types of recurrent cancer and have tried standard treatments without success.
For the Expansion Phase, must have a confirmed diagnosis of certain types of recurrent cancer, with specific treatment history and conditions.
Must have completed prior cancer treatments within specific time frames before starting the study drug.
Must have stabilized or recovered from side effects of previous treatments, except for hair loss.
Must have tumors that can be evaluated by imaging tests.
Must provide tumor tissue samples for testing.

Who Cannot Join the Study?

Patients who are not female cannot participate in the study.
Patients who are not considered part of a vulnerable population cannot participate in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Hopital De Libramont	Libramont-Chevigny	Belgium
MD Anderson Cancer Center	Madrid	Spain
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Ipdpuhmx Rnjgnlpf Dy Cfyenq Dm Mcwmwvianjj	Montpellier	France
Hqfoed Dzz Hxhlz Slotpjp Kxavppph Wihkqpylk Gynu	Wiesbaden	Germany
Ckfbfk Lvzn Bfqrpe	Lyon	France
Uqrjrtwdbcrq Mfabadu Cmxzydd Gokqmathc	Groningen	The Netherlands
Faanrfqfm Pkbt Ly Iafdbiqldhuxx Bdqlomxde Dfe Hilreeck Ufjydvetmrabq Lu Pyz	Madrid	Spain
Elymzet Ujhzakkgulkl Mglyswn Cdghhrc Rnjxklaib (rmndbdw Mwn	Rotterdam	The Netherlands
Imtlwryg Cqdstc Ddsjuntrpondzfbvt	L'hospitalet De Llobregat	Spain
Kzszopui Ewffdogkfixfdgbmgnvfhohi Hjmbqnjfkxjnjphvq	Essen	Germany
Hylgwrrs Vrpy deiahqpt	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.01.2025
France	Not recruiting	01.01.2025
Germany	Not recruiting	01.01.2025
Ireland	Not recruiting	01.01.2025
Italy	Not recruiting	01.01.2025
Spain	Not recruiting	01.01.2025
The Netherlands	Not recruiting	01.01.2025

Trial locations

Investigated drugs:

IMGN151 is an experimental medication being studied for its potential to treat certain types of cancer. It is an antibody-drug conjugate, which means it combines an antibody with a drug to specifically target and kill cancer cells. In this trial, IMGN151 is being tested in adult patients with recurrent endometrial cancer and recurrent, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancers. The study aims to determine the safety and tolerability of IMGN151, as well as the most effective dose for future studies.

Recurrent Endometrial Cancer – This type of cancer occurs when cancer cells form in the lining of the uterus and return after treatment. It often involves abnormal bleeding and pelvic pain. The cancer can spread to nearby tissues or distant organs. Over time, it may become more resistant to standard treatments, making it challenging to manage.

Recurrent High-Grade Serous Epithelial Ovarian Cancer – This aggressive form of ovarian cancer originates in the cells on the surface of the ovary and tends to recur after initial treatment. It is characterized by rapid growth and a tendency to spread to other parts of the body. Symptoms may include abdominal bloating, pain, and changes in bowel habits. The cancer often becomes more difficult to treat with each recurrence.

Recurrent Primary Peritoneal Cancer – This cancer is similar to ovarian cancer but starts in the peritoneum, the lining of the abdominal cavity. It can recur after initial treatment, presenting symptoms like abdominal pain and swelling. The disease may spread to other organs within the abdomen. As it progresses, it can become more challenging to control.

Recurrent Fallopian Tube Cancer – This rare cancer begins in the fallopian tubes and can return after treatment. It shares similarities with ovarian cancer, including symptoms like pelvic pain and abnormal bleeding. The cancer may spread to nearby organs or tissues. With recurrence, it often becomes more resistant to therapies.

Trial ID:

2023-506842-22-00

Protocol code:

IMGN151-1001

NCT ID:

NCT05527184

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Effectiveness of IMGN151 for Women with Recurrent Endometrial and Ovarian Cancer

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