Study of Disitamab Vedotin for Adults with Previously Treated HER2-Positive Solid Tumors, Including Lung, Head and Neck, Ovarian, and Endometrial Cancers

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called Disitamab Vedotin on certain types of cancer. The cancers being studied include Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Ovarian Cancer, and Endometrial Cancer. These cancers are known to express a protein called HER2, which is involved in the growth of cancer cells. The treatment, Disitamab Vedotin, is a special type of medication that targets this protein to help fight the cancer.

The purpose of the study is to evaluate how well Disitamab Vedotin works in treating these cancers. Participants in the study will receive the treatment as a powder mixed into a solution, which is then given through an infusion. The study will follow participants over a period of time to observe the effects of the treatment on their cancer. Some participants may receive a placebo, which is a substance with no active medication, to compare the results.

Throughout the study, researchers will monitor the participants’ health and any changes in their cancer. They will look at how the cancer responds to the treatment, any side effects that occur, and how long the effects last. The study aims to provide valuable information on the effectiveness and safety of Disitamab Vedotin for these types of cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria related to the type of cancer and previous treatments.

The study involves patients with certain types of cancer, including non-small-cell lung cancer, squamous cell carcinoma of the head and neck, ovarian cancer, and endometrial cancer.

Patients must have tumors that express a protein called HER2, which is determined through a test on tumor tissue.

2 treatment administration

The treatment involves the administration of a medication called disitamab vedotin.

This medication is provided as a powder for solution for infusion, meaning it is given through a drip into a vein.

The frequency and dosage of the medication are determined by the study protocol and the patient’s specific condition.

3 monitoring and assessments

Throughout the study, regular assessments are conducted to monitor the response to the treatment.

These assessments include measuring the size of the tumor and checking for any side effects.

The study aims to evaluate the effectiveness of the treatment in controlling the disease and improving survival.

4 completion of the study

The study is expected to continue until March 2028, with regular follow-ups to assess long-term outcomes.

Upon completion, the results will be analyzed to determine the overall benefits and risks of the treatment.

Who Can Join the Study?

Must have one of the following types of cancer: non-small-cell lung cancer, squamous cell carcinoma of the head and neck, ovarian cancer, or endometrial cancer.
Cancer must be unresectable, meaning it cannot be removed by surgery, and must be locally advanced or have spread to other parts of the body (metastatic).
Must have received certain prior treatments, such as platinum-based therapy (a type of chemotherapy) and possibly anti-PD(L)1 therapy, depending on the type of cancer.
Must not have received more than a specific number of prior chemotherapy treatments for advanced disease, which varies by cancer type.
Cancer must show HER2 expression, which is a protein found on some cancer cells, at levels of 1+, 2+, or 3+ as determined by a test called IHC.
Must have measurable disease according to specific criteria used by doctors to assess cancer size and spread.
Must be able to provide a sample of tumor tissue for testing.
Must have an ECOG performance status score of 0 or 1, which indicates the ability to carry out daily activities.
Both male and female participants are eligible.
Participants must be within certain age ranges, typically adults.

Who Cannot Join the Study?

Patients who have not been previously treated for their cancer.
Patients with tumors that can be surgically removed.
Patients whose tumors do not express HER2, a protein that can affect the growth of cancer cells.
Patients who are not in the age range specified for the study.
Patients who are not able to provide informed consent or understand the study requirements.
Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have had a recent major surgery or are recovering from surgery.
Patients with a history of severe allergic reactions to similar treatments.

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
Centr Georges Francois Leclerc	Dijon	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Hospital Del Mar	Barcelona	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Francois Baclesse	Caen	France
Ccprty Lint Buvgvy	Lyon	France
Keylbnpn Egdoueaelfpbkenfrpttjcuy Hhtqjiotrgjsqbdet	Essen	Germany
Hgmxdnpm Vfxr dzuajegh	Barcelona	Spain
Jioikuddxo Gwgy Jmnyndkqzgksrygdvrlxyh	Bonn	Germany

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.08.2024
Germany	Not recruiting	01.08.2024
Italy	Not recruiting	01.08.2024
Spain	Not recruiting	01.08.2024

Trial locations

Investigated drugs:

Disitamab Vedotin

Disitamab Vedotin is a medication being studied for its ability to treat certain types of cancer. It is used in patients who have already received treatment for their cancer, but the cancer has either spread or cannot be removed with surgery. This medication targets tumors that express a protein called HER2, which can promote the growth of cancer cells. The goal of using Disitamab Vedotin in this trial is to see how well it can reduce or control the growth of these tumors.

Investigated diseases:

Non-Small-Cell Lung Carcinoma – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma and squamous cell carcinoma. It generally grows and spreads more slowly than small-cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can spread to other parts of the body, including the bones and brain. It is often diagnosed at an advanced stage due to the subtlety of early symptoms.

Squamous Cell Carcinoma of Head and Neck – This cancer originates in the squamous cells lining the moist surfaces inside the head and neck. It can affect areas such as the mouth, throat, and nose. Symptoms may include a sore throat, difficulty swallowing, and a lump in the neck. The disease can progress by invading nearby tissues and spreading to lymph nodes. It is often linked to risk factors like tobacco and alcohol use.

Ovarian Neoplasms – These are tumors that occur in the ovaries, which can be benign or malignant. Malignant ovarian neoplasms, or ovarian cancer, often present with vague symptoms like bloating, pelvic pain, and changes in bowel habits. The disease can progress by spreading to the abdominal lining and other organs. Early detection is challenging due to the non-specific nature of symptoms.

Endometrial Neoplasms – These are tumors that develop in the lining of the uterus, known as the endometrium. The most common type is endometrial carcinoma, which often presents with abnormal uterine bleeding, especially post-menopause. As the disease progresses, it can invade the uterine muscle and spread to other pelvic organs. Risk factors include obesity, hormone therapy, and a history of certain genetic conditions.

Trial ID:

2023-504445-31-00

Protocol code:

C5731005 / SGNDV-005

NCT ID:

NCT06003231

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Disitamab Vedotin for Adults with Previously Treated HER2-Positive Solid Tumors, Including Lung, Head and Neck, Ovarian, and Endometrial Cancers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?