Gastric cancer stage IV Trials in Disease

Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

This trial is testing a new treatment called DS-3939a for patients with advanced or metastatic solid tumors, including gastric cancer. The medication is delivered directly into the bloodstream through an intravenous infusion. The study is divided into two parts: the first part focuses on safety and tolerability, while the second part measures how effective the treatment is at shrinking or controlling tumors.

Main inclusion criteria: Participants must be at least 18 years old and sign an informed consent form. They should have a heart function measure of at least 50 percent and adequate organ function overall. The cancer must be measurable according to standard criteria, and participants should have an Eastern Cooperative Oncology Group performance status of 0 or 1, meaning they are fully active or have some symptoms but can carry out light work. For Part 1, patients must have confirmed locally advanced, metastatic, or unresectable cancer in specific organs including the stomach. For Part 2, patients need to show disease progression on scans during or after their most recent treatment and be able to provide a tumor sample.

Main exclusion criteria: Patients who do not meet the specified age requirements or who are part of vulnerable populations, such as pregnant women or those unable to give consent, cannot participate. Those who do not meet the safety and tolerability requirements for DS-3939a are also excluded.

Trial focus: The main goal is to evaluate the safety and tolerability of DS-3939a and to see how well it works in treating advanced solid tumors. The study will measure the objective response rate, which is the percentage of patients whose cancer shrinks or disappears after treatment. Throughout the trial, participants will be closely monitored with regular check-ups, laboratory tests, and imaging studies.

Investigational drug: DS-3939a is an experimental medication designed to target specific pathways that cancer cells use to grow and spread. It is administered as an intravenous solution and is currently being studied for its potential in treating advanced and metastatic solid tumors.

Study on Gallium (68Ga) Tezatabep Matraxetan PET for Evaluating HER2 Status in Patients with Gastro-Esophageal and HER2-Low Breast Cancer

This trial is focused on patients with gastroesophageal cancer and HER2-low breast cancer. It uses a special imaging technique called PET/CT to evaluate a protein called HER2, which can affect cancer growth. The study involves an imaging agent known as [68Ga]Ga-ABY-025, which is injected into the body to help highlight cancer cells during the scan.

Main inclusion criteria: Participants must be 18 years or older and provide written consent. They should have metastatic disease due to gastroesophageal adenocarcinoma with HER2-positive status, non-small cell lung cancer with HER2-positive status, or HER2-low metastatic breast cancer. Patients must have at least one metastatic lesion that is 10 millimeters or larger available for biopsy, plus one to five additional lesions for evaluating treatment effects. They should have a WHO performance status of 2 or less and an expected survival of more than 12 weeks.

Main exclusion criteria: Patients who do not have gastroesophageal cancer with HER2-expression or breast cancer with low HER2-expression cannot participate. Those outside the specified age range or who are part of vulnerable populations are also excluded.

Trial focus: The purpose is to evaluate how well [68Ga]Ga-ABY-025 can identify HER2 status in tumors and any areas where the cancer has spread. This imaging method helps doctors understand more about the HER2 characteristics of the tumors, which is important for planning the best treatment approach. Participants will undergo PET/CT scans to monitor how the imaging agent is taken up by cancer cells.

Investigational drug: [68Ga]Ga-ABY-025 is a radiopharmaceutical imaging agent used in PET/CT scans. It works by binding to the HER2 protein on cancer cells, allowing doctors to see these cells more clearly on imaging scans. This helps in diagnosis and treatment planning for cancers that express the HER2 protein.

Summary

The two ongoing clinical trials for gastric cancer stage IV offer different approaches to understanding and treating the disease. One trial focuses on testing a new experimental treatment called DS-3939a that targets cancer cell growth pathways, while the other uses advanced imaging techniques to better understand HER2 protein expression in tumors. The trials are spread across Belgium, France, Spain, and Sweden, with the DS-3939a study being conducted in three countries. Both trials aim to provide valuable information that could lead to better treatment strategies for patients with advanced cancers, including gastric cancer stage IV.