Study of Disitamab Vedotin and Tucatinib for Patients with Advanced Breast Cancer or Gastric Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for certain types of cancer, specifically locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma, as well as locally advanced metastatic breast cancer. The treatment being tested involves a medication called Disitamab Vedotin, which is used alone or in combination with another drug called Tucatinib. The purpose of the study is to find the best dose of Disitamab Vedotin when used with Tucatinib and to understand how safe and tolerable these treatments are for patients.

Participants in the study will receive Disitamab Vedotin, which is given as an infusion, meaning it is administered directly into the bloodstream through a vein. Tucatinib is taken as a tablet by mouth. The study will explore how these treatments work in different groups of patients, including those with HER2-low and HER2-positive breast cancer, as well as those with HER2-low gastric cancer. HER2 is a protein that can affect the growth of cancer cells, and the study will look at how the treatments perform in patients with varying levels of this protein.

Throughout the study, researchers will monitor participants for any side effects and will assess how well the cancer responds to the treatment. The study aims to gather information on the safety of the treatments and their ability to control or reduce the cancer. This information will help determine the potential benefits of using Disitamab Vedotin and Tucatinib for these types of cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

Eligibility criteria include being 18 years or older, having a confirmed diagnosis of specific types of cancer, and having experienced disease progression after standard treatments.

2 treatment phase

The treatment phase involves receiving disitamab vedotin and tucatinib. Disitamab vedotin is administered as an intravenous infusion, while tucatinib is taken orally in the form of film-coated tablets.

The dosage and frequency of administration are determined based on the specific cohort and treatment plan.

3 monitoring and evaluation

Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes checking for any side effects and evaluating the response to the treatment.

The primary focus is on identifying the maximum tolerated dose and assessing the antitumor activity of the medications.

4 follow-up

After completing the treatment phase, follow-up assessments are conducted to monitor long-term effects and overall health status.

These assessments help in understanding the duration of response and overall survival rates.

Who Can Join the Study?

Must be at least 18 years old or considered an adult by local regulations.
Must have a confirmed diagnosis of either gastric or gastroesophageal junction adenocarcinoma or breast carcinoma.
The cancer must be in a locally-advanced, unresectable, or metastatic stage, meaning it cannot be removed by surgery and may have spread to other parts of the body.
Must have a specific HER2 status, which is a protein that can affect the growth of cancer cells. This status is determined by a recent local assessment.
Must have experienced disease progression after standard treatments or be unable to tolerate these treatments.
For those with HER2-Low Breast Cancer, must have a confirmed diagnosis of breast carcinoma and meet specific prior therapy requirements.
For those with HER2+ Breast Cancer, must have a confirmed diagnosis of breast carcinoma and have received certain prior treatments.
For those with HER2-Low Gastric or Gastroesophageal Junction Adenocarcinoma, must have a confirmed diagnosis and meet specific prior therapy requirements.
Must have measurable disease according to specific medical guidelines.
Must have a good performance status, meaning they are able to carry out daily activities with minimal assistance.
Must have adequate heart function, as determined by specific tests.
Must have adequate bone marrow, liver, and kidney function based on recent laboratory tests.
If able to become pregnant, must have a negative pregnancy test and agree to use effective birth control during the study and for a specified time after the study.
If able to get someone pregnant, must agree to use effective birth control during the study and for a specified time after the study.
Must be willing and able to follow study procedures and requirements, including keeping a daily record of medication use.

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied cannot participate.
Patients who are not in the age range specified for the study cannot participate.
Patients who are not able to follow the study procedures or take the study medications cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies to the study medications cannot participate.
Patients who have not recovered from previous treatments or surgeries cannot participate.
Patients who have certain infections or diseases that could affect the study cannot participate.
Patients who are unable to provide informed consent cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Charite Research Organisation GmbH	Berlin	Germany
Humanitas Istituto Clinico Catanese S.p.A.	Misterbianco	Italy
Hospital Universitario Basurto	Bilbao	Spain
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Hopital Beaujon	Clichy	France
Uudgfauufzxyhwvvuukzg Etmlh Amy	Essen	Germany
Ighqzjdg Cmxbfn Dhciruunkwlnwlnuh	L'hospitalet De Llobregat	Spain
Hwqnbudg Vijj dprjwcwi	Barcelona	Spain
Imegceil Pvvaprgccrnrula Ccqceq Cosilv	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	31.07.2024
Germany	Recruiting	31.07.2024
Italy	Recruiting	31.07.2024
Spain	Recruiting	31.07.2024

Trial locations

Investigated drugs:

Disitamab Vedotin is a medication being studied for its potential to treat certain types of advanced cancers. It is used alone or in combination with other cancer treatments. The study aims to find the best dose and to understand how safe and tolerable it is for patients with specific types of breast cancer and gastric cancer.

Tucatinib is another medication involved in the study, used in combination with Disitamab Vedotin. It is being tested to see how well it works with Disitamab Vedotin in treating advanced breast cancer and gastric cancer. The study is also looking at the safety and side effects of using these two medications together.

Investigated diseases:

Locally Advanced Unresectable or Metastatic Gastric Cancer – This type of cancer originates in the stomach and has progressed to a stage where it cannot be surgically removed. It may spread to nearby tissues or distant organs, making it challenging to manage. The disease often leads to symptoms such as difficulty swallowing, weight loss, and stomach pain. As it advances, it can affect the digestive system and overall health. The progression can vary, with some cases remaining stable for a period while others may spread more rapidly.

Gastroesophageal Junction Adenocarcinoma – This cancer occurs where the esophagus meets the stomach, known as the gastroesophageal junction. It typically begins in the glandular cells lining this area and can spread to nearby structures. Symptoms may include difficulty swallowing, chest pain, and weight loss. The disease can progress by invading surrounding tissues and potentially spreading to distant organs. Its development is often linked to factors like chronic acid reflux and obesity.

Locally Advanced Metastatic Breast Cancer – This form of breast cancer has spread beyond the breast to nearby lymph nodes or other parts of the body. It may present with symptoms such as a lump in the breast, changes in breast shape, or skin dimpling. As the disease progresses, it can affect other organs, leading to additional symptoms depending on the areas involved. The progression can vary widely among individuals, with some experiencing slow growth and others facing more aggressive spread.

Trial ID:

2023-507555-29-00

Protocol code:

C5731004 – SGNDV-004

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Disitamab Vedotin and Tucatinib for Patients with Advanced Breast Cancer or Gastric Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?