Clinical study with Patritumab Deruxtecan in people with gastrointestinal cancer

Zusammenfassung der Studie

This study is being conducted to: - investigate the safety of Patritumab Deruxtecan - see how well and how long Patritumab Deruxtecan works - see if Patritumab Deruxtecan helps participants live longer and prevents their cancer from worsening - measure what happens when Patritumab Deruxtecan goes through the body. Approximately 130 people are expected to participate in this study worldwide, with about 6 people in Switzerland. The total study duration is approximately 5 years. Investigational drug: Patritumab Deruxtecan is being studied for the treatment of various types of cancer and is not approved for sale. Patritumab Deruxtecan is a special type of cancer treatment called antibody-drug conjugate (ADC). It is a monoclonal antibody to which chemotherapy is attached. A monoclonal antibody is a molecule that targets specific cancer cells, but it can also bind to healthy cells in the human body. Chemotherapy is a type of cancer treatment that kills rapidly growing and dividing cells. This usually involves cancer cells, but healthy cells can also be affected. Patritumab Deruxtecan targets cells that express the HER3 molecule. HER3 is one of many proteins on the surface of cancer cells. A protein is a large molecule that is important for many processes in and around body cells. Research has shown that the HER3 protein level can be elevated in various types of cancer cells. Patritumab Deruxtecan is designed to deliver chemotherapy directly into HER3-positive cancer cells to kill them. The chemotherapy component of Patritumab Deruxtecan may also act on surrounding cancer cells that may not express the HER3 protein.

(BASEC)

Untersuchte Intervention

After detailed information, an eligibility assessment of about 28 days, and collection of medical history, the patient will be enrolled in the study and assigned to one of three treatment groups based on their disease:

• Group 1: patients with colorectal cancer (approximately 40 participants)

• Group 2: patients with cholangiocarcinoma (approximately 40 participants)

• Group 3: patients with hepatocellular carcinoma (approximately 50 participants)

Patritumab Deruxtecan will be administered every 3 weeks through a needle in the arm. This is called intravenous infusion.

In groups 1 and 2, participants will receive 5.6 mg/kg of Patritumab Deruxtecan. In group 3, two doses of Patritumab Deruxtecan will first be tested for safety (4.8 mg/kg (starting dose) or 5.6 mg/kg), this occurs in a phase called the “dose escalation phase.” Additional doses (in between or lower) may be considered depending on the safety profile of the two initial doses. The recommended dose deemed safe in phase 2 will then be further evaluated for its efficacy (“efficacy phase”).

This study is referred to as a “open-label” study. This means that both the participants and the investigator and sponsor know which group the participants have been assigned to and thus which study medication they are receiving.

During study visits, various measures and examinations may occur, e.g.: blood and urine tests, tumor biopsy sampling, imaging studies (computed tomography (CT), magnetic resonance imaging (MRI), X-rays or bone scans), heart examinations (electrocardiograms (ECG), echocardiograms or radionuclide ventriculography (MUGA scan)), physical examinations (e.g., of the gastrointestinal tract via endoscopy or an eye examination), assessment of general health status, and discussions with medical staff.

The study team may also contact participants between hospital visits and after the completion of the study drug administration to check on their health status.

(BASEC)

Untersuchte Krankheit(en)

Given the unmet medical need for patients with gastrointestinal cancers, new agents are needed. This study investigates three different types of cancer: colorectal cancer, cholangiocarcinoma, and hepatocellular carcinoma. - Colorectal cancer is the third most diagnosed cancer worldwide. In 2022, approximately 1.9 million new cases were diagnosed, accounting for about 10% of all cancer cases. It is the second leading cause of cancer-related death, with about 900,000 deaths annually. The 5-year survival rate for metastatic colorectal cancer (cancer that has formed metastases) is only 14%, highlighting the need for new and effective therapies. - Cholangiocarcinoma includes cancers of the bile ducts (cholangiocarcinoma) as well as the gallbladder. In the United States, approximately 13,500 new cases of metastatic cholangiocarcinoma were estimated for the year 2023. A 5-year survival rate of only 2% to 3% shows the poor prognosis for affected individuals. - Hepatocellular carcinoma is the third leading cause of cancer-related death worldwide and the sixth most diagnosed cancer globally. Over 80% of these cases are hepatocellular carcinomas. The number of new cases and mortality rates of these carcinomas are rising worldwide.

(BASEC)

Sponsor

MSD Merck Sharp & Dohme AG, Luzern

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Genf

(BASEC)

Datum der Bewilligung durch die Ethikkommission

07.11.2024

(BASEC)

Ergebnisse der Studie