The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Locally Advanced or Metastatic Solid Tumors, including Ewing Sarcoma and Colorectal Adenocarcinoma. The purpose of this study is to learn about the effects of the study drug, INBRX-109, on you, your immune system, and your specific cancer. This is the first study to test INBRX-109 in humans. Most important, this study is being done to understand how safe this drug is. The study will find out what the well-tolerated dose for patients is and which side effects the drug may cause. The study will also assess how much this drug can slow the growth of cancer. INBRX 109 is an experimental drug, which means the drug has not been approved by any authority that regulates new medications, including the United States Food and Drug Administration (FDA) or any other international regulatory/government agencies.
INBRX-109 will be studied in combination with the following standard chemotherapy regimens depending on your type of cancer:
1. Irinotecan and temozolomide (chemotherapy) in participants with Ewing sarcoma, or
2. Fluorouracil, leucovorin and irinotecan (chemotherapy) in participants with colorectal adenocarcinoma (a cancer that occurs in the colon or rectum).
The study involves receiving the study drugs, as well as coming in for study visits, which include exams, laboratory tests, imaging scans, procedures such as having your blood drawn, and talking to the study doctor. If you decide to take part in this study you will receive INBRX-109 once every 3 or 4 weeks (depending on the drug given in combination), for as long as you can tolerate the study treatment, and for as long as the study treatment provides you with benefits regarding your cancer treatment
The length of time you will be in the study also includes a Screening period of up to 3 weeks. After you finish study treatment, your Study Doctor will continue to follow-up with you at least once every 3 months. This allows your Study Doctor to watch for any side effects and follow your condition. This will be done for at least 12 months or until you decide that you no longer want to participate and withdraw consent.
The study drug INBRX-109 will be provided by the sponsor at no cost to you. All additional study procedures that are beyond your standard medical care, including laboratory tests, physical examinations, and visits to the study center, are provided to you at no charge.
Additional information can be found here: https://clinicaltrials.gov/study/NCT03715933
Stipend/Travel Reimbursement - $65 per visit Hotel Reimbursement - $200 per night