Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

To join this study, people need to be between 12 and 85 years old, with the exact age range depending on the type of cancer. For Ewing sarcoma, participants can be aged 12 and over, while for other cancers it's 18 and over, but generally under 85. You must have advanced Ewing sarcoma or bowel cancer that is locally advanced (spread to nearby areas) or metastatic (spread to other parts of the body), which has either come back or hasn't responded to previous treatments. For Ewing sarcoma, you should have had one or two prior rounds of chemotherapy. For bowel cancer, you might have had one, two, or three previous treatments, depending on the specific drugs used in those treatments.

Your cancer must be measurable, meaning doctors can track its size. You'll also need to be generally well enough to take part, with good overall health as assessed by your doctors, including healthy blood counts and good kidney and liver function. You should also have an estimated life expectancy of at least 12 weeks. The research team will need to examine a sample of your cancer tissue, either an existing one or a new biopsy.

There are also reasons why someone might not be able to join. For example, if you've previously received a similar type of drug that targets DR5, or if you've had recent radiation therapy or other cancer treatments. Also, if you have severe allergies to certain medications or have had a bone marrow transplant recently (within the last 5 years), you might not be eligible. The study ensures that participants are as safe as possible and that the results are clear, so these criteria help to protect patients and keep the study focused.

If you decide to take part in this study, you will receive the new drug, INBRX-109, either on its own or in combination with other standard cancer medicines, based on your specific cancer type and the study plan. You will have regular appointments at the hospital or clinic. These visits will involve blood tests, physical examinations, and scans (like CT scans) to monitor your health, how the drug is affecting you, and if your cancer is responding. The schedule of these visits and tests will be detailed by the study team, but they will be more frequent at the beginning of the treatment to closely monitor safety. You'll continue treatment for as long as it's helping and you're not experiencing severe side effects. After treatment finishes, there will be follow-up appointments to check on your long-term health. The total duration of your participation could vary, from several months during active treatment to longer if you continue to be monitored.