The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Unresectable or Metastatic Hepatocellular Carcinoma (HCC) not previously treated with Systemic Therapy. The purpose of this study is to test the effectiveness of the investigational drug TPST-1120 given in combination with 2 currently approved drugs for hepatocellular carcinoma (HCC), known as atezolizumab and bevacizumab, when compared to placebo (a product without any active ingredients) given in combination with atezolizumab and bevacizumab. Investigational means that TPST-1120 has not been approved by the U. S. Food and Drug Administration (FDA) to treat HCC and is considered experimental. You will have an equal chance (50:50) of receiving the study drug (TPST-1120) or the placebo. This study is a double-blind study, which means that you, your study doctor and study team will not know which treatment group you are assigned to.
The study involves receiving the investigational drug or placebo, 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 complete 3 study periods: Screening, Treatment, and Long-Term Follow-Up. The Screening period includes coming in for one or more Screening Visits before you start treatment (up to 28 days before), to determine if this study is suitable for you. The Treatment period consists of 21-day (3 week) cycles. You will take the TPST-1120 or placebo by mouth every day of the cycle, and you must come to the study site on Day 1 of each cycle, where you will receive atezolizumab and bevacizumab. You may continue to receive the study drugs in 21-day cycles as long as you do not have unacceptable side effects, and your study doctor believes you are benefiting from the study drugs. The Follow-Up period beings when you stop receiving the study drugs. This period will include an End of Treatment visit (within 30 days after your last dose of study drug) and if your cancer has not worsened at the time you stop receiving the study drugs, disease Follow-up visits either every 9 or 12 weeks (depending on the length of time you have been in the study) until your cancer worsens. You or your nominated representative(s) will then be contacted every 3 months about your health status and your anti-cancer treatments. Not all patients will stay in the study for the same amount of time. The number of cycles of the study drugs you receive will depend on any side effects you experience, your health and whether the study doctor considers that the study drugs are beneficial for you. The total number of visits you attend will depend on how long you remain in the study.
The study drugs, TPST-1120 and Atezolizumab, 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/NCT06680258
Stipend/Travel Reimbursement - $65 per visit Hotel Reimbursement - $200 per night