Study on the Safety and Effectiveness of Trastuzumab Deruxtecan and Drug Combination for Patients with HER2-Positive Gastric, GEJ, and Esophageal Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer known as HER2-expressing gastric cancer, which includes cancers of the stomach, gastroesophageal junction (GEJ), and esophagus. The study is investigating the effects of a treatment called trastuzumab deruxtecan, also known by its code name DS-8201a. This treatment is being tested both on its own and in combination with other medications, including capecitabine, fluorouracil, oxaliplatin, durvalumab, volrustomig (also known as MEDI5752), and rilvegostomig (also known as AZD2936).

The purpose of the study is to evaluate the safety and effectiveness of these treatments in patients with this type of cancer. The study is divided into different parts. Initially, it will focus on determining the safest dose of trastuzumab deruxtecan when used in combination with the other medications. Later parts of the study will assess how well these combinations work in controlling the cancer. Participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein.

Throughout the study, researchers will monitor participants for any side effects and measure how the cancer responds to the treatment. The study aims to find the best dose and combination of treatments to help manage HER2-expressing gastric cancer effectively. The study is expected to continue until 2026, with the goal of improving treatment options for patients with this type of cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the patient meets the study criteria.

2 treatment phase 1

In the first part of the treatment, the patient receives **trastuzumab deruxtecan** (T-DXd) as a monotherapy or in combination with other medications. The goal is to assess safety and determine the appropriate dosage.

The medication is administered through an intravenous infusion, which means it is given directly into the bloodstream through a vein. The frequency and duration of administration depend on the specific protocol of the study.

3 treatment phase 2

In the subsequent phases, the patient continues to receive **T-DXd** in combination with other agents such as **capecitabine**, **5-fluorouracil**, **oxaliplatin**, and **durvalumab**. These combinations aim to evaluate the antitumor activity at the recommended dose.

The medications are administered either intravenously or orally, depending on the specific drug. The treatment schedule is determined by the study protocol.

4 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess the patient’s response to the treatment. This includes checking for any side effects, changes in vital signs, and conducting laboratory tests.

Follow-up visits are scheduled to evaluate the overall health and progress of the patient. Adjustments to the treatment may be made based on these assessments.

5 end of trial

At the conclusion of the trial, a final assessment is conducted to determine the overall effectiveness of the treatment. This includes evaluating the tumor response and any long-term effects of the medication.

The patient may be asked to participate in additional follow-up visits to monitor their health after the trial has ended.

Who Can Join the Study?

Participants must be at least 18 years old.
Participants must have a type of cancer called adenocarcinoma in the stomach, gastroesophageal junction (GEJ), or esophagus. This cancer must show certain levels of a protein called HER2.
For some parts of the study, participants must have cancer that has progressed after at least one previous treatment that included a drug called trastuzumab. For other parts, participants must not have received any treatment for their cancer that cannot be removed by surgery or has spread to other parts of the body.
Participants must have measurable disease, which means the cancer can be measured by the doctor using specific guidelines.
Participants must have adequate bone marrow and organ function, including heart, kidney, and liver function, as defined by the study.
If participants can have children, they must agree to use a highly effective form of birth control or avoid sexual intercourse during the study and for a certain period after the study ends (7 months for females and 6 or 4 months for males, depending on the treatment group).

Who Cannot Join the Study?

Patients who do not have Human Epidermal Growth Factor Receptor 2 (HER2)-expressing gastric, GEJ, or esophageal cancer cannot participate. HER2 is a protein that can affect the growth of cancer cells.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not willing or able to follow the study procedures cannot participate.
Patients who have other medical 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 or reactions to the study drugs cannot participate.
Patients who have certain heart conditions or other serious health issues cannot participate.
Patients who are taking medications that might interfere with the study drugs cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland
Universitaet Leipzig	Leipzig	Germany
Haematologisch Onkologische Praxis Eppendorf	Hamburg	Germany

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Istituto Oncologico Veneto	Padua	Italy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Opole	Poland
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o.	Tomaszow Mazowiecki	Poland
Virgen del Rocío University Hospital	Sevilla	Spain
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Netherlands Cancer Institute	Amsterdam	The Netherlands
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hgjqypxz Uhezwxcdhlhbf Mysyiul Di Vgopypkvtx	Santander	Spain
Amggtdeid Uyy	Amsterdam	The Netherlands
Nbivzezv Icffdimm Oanxrbwpe Iqv Mmixh Sfzzsqgnurulpdfonawmoucwjdyi Idbwzlkc Bxiftcrz	Cracow	Poland
Ubqgmkbsftzpbr Cyiwngb Kcsamhztt	Gdansk	Poland
Prhhdolboly Lwknenuz &lswckefxcgkcxhzcubh Rnzad Kktccymytey	Konin	Poland
Gxflmj Uzvzbmzrjl Fmeiydich	Frankfurt	Germany
Hehzllxt Vhot drwjqsrp	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	02.06.2020
Italy	Recruiting	02.06.2020
Poland	Recruiting	02.06.2020
Spain	Recruiting	02.06.2020
The Netherlands	Not recruiting	02.06.2020

Trial locations

Investigated drugs:

Trastuzumab Deruxtecan (T-DXd) is a medication used in this trial to treat gastric cancer that expresses a protein called HER2. It works by delivering a powerful anti-cancer drug directly to the cancer cells, which helps to stop their growth and spread. This medication is being tested alone and in combination with other treatments to see how well it works and how safe it is for patients.

Capecitabine is a type of chemotherapy that is used to treat various cancers, including gastric cancer. It works by interfering with the DNA of cancer cells, which prevents them from growing and dividing. In this trial, capecitabine is combined with other medications to evaluate its effectiveness in treating HER2-expressing gastric cancer.

5-Fluorouracil is another chemotherapy drug used in this study. It targets cancer cells by disrupting their DNA and RNA, which are essential for cell growth and division. This medication is being tested in combination with others to determine its role in treating gastric cancer.

Oxaliplatin is a chemotherapy drug that is used to treat gastric cancer by damaging the DNA of cancer cells, which stops them from multiplying. In this trial, oxaliplatin is combined with other treatments to assess its safety and effectiveness in patients with HER2-expressing gastric cancer.

Durvalumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It works by blocking a protein that prevents the immune system from attacking cancer cells. In this study, durvalumab is used in combination with other medications to evaluate its potential benefits for patients with gastric cancer.

Human Epidermal Growth Factor Receptor 2 (HER2)-expressing Gastric Cancer – This type of cancer occurs in the stomach and is characterized by the overexpression of the HER2 protein, which promotes the growth of cancer cells. It typically begins in the cells lining the stomach and can spread to other parts of the body. As the disease progresses, it may invade deeper layers of the stomach wall and spread to nearby lymph nodes and organs. Symptoms often include difficulty swallowing, weight loss, and stomach pain. The progression can lead to more severe symptoms as the cancer advances and affects more areas. HER2-expressing gastric cancer is a specific subtype that may respond differently to certain treatments compared to other gastric cancers.

Human Epidermal Growth Factor Receptor 2 (HER2)-expressing Gastroesophageal Junction Cancer – This cancer occurs where the esophagus meets the stomach, known as the gastroesophageal junction, and involves the overexpression of the HER2 protein. It begins in the cells lining this area and can spread to nearby tissues and organs. As it progresses, the cancer may invade deeper layers and spread to lymph nodes and distant sites. Symptoms can include difficulty swallowing, chest pain, and weight loss. The disease’s progression can lead to more severe symptoms and complications. HER2-expressing gastroesophageal junction cancer is a distinct subtype that may have unique treatment responses.

Human Epidermal Growth Factor Receptor 2 (HER2)-expressing Esophageal Cancer – This type of cancer affects the esophagus and is marked by the overexpression of the HER2 protein, which can accelerate cancer cell growth. It typically starts in the cells lining the esophagus and can spread to other parts of the body. As the disease advances, it may penetrate deeper into the esophageal wall and spread to nearby lymph nodes and organs. Common symptoms include difficulty swallowing, chest pain, and unintentional weight loss. The progression can lead to more severe symptoms and potential complications. HER2-expressing esophageal cancer is a specific subtype that may respond differently to certain treatments compared to other esophageal cancers.

Trial ID:

2023-504888-16-00

Protocol code:

D967LC00001

NCT ID:

NCT04379596

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Trastuzumab Deruxtecan and Drug Combination for Patients with HER2-Positive Gastric, GEJ, and Esophageal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?