What is the Purpose of this Study?
This study focuses on people who have a specific type of cancer that is either recurrent (has come back), locally spread, or metastatic (has spread to a different body part) and has not responded to approved treatments. The purpose of the study is to learn about the safety and effects of an experimental drug called TEV-56278, in addition to identifying the best dose of the drug. TEV-56278 may potentially help the immune system target and fight cancer cells directly at the tumor site and possibly enhance the body’s natural defense against cancer. The study also aims to determine whether TEV-56278 will help stabilize, limit, or slow the worsening of the cancer type the patient has been diagnosed with. Researchers will measure the amount of TEV-56278 in the blood at various times and determine whether the body makes antibodies (proteins produced by the body's immune system when it detects harmful substances) against TEV-56278, as well as evaluate the effect that the drug may have on the immune system.
Eligibility
- * Have an established histological diagnosis of selected solid tumor and must have received and progressed on established standard therapies or have been intolerant to such therapy or have been considered by the Investigator as ineligible for approved standard therapy
- * Have a life expectancy≥12 weeks at the time of the screening
- * Women of childbearing potential must agree to use highly effective methods of contraception for the course of the trial through 120 days after the last dose of trial medication
- * Males who are sexually active with women of childbearing potential must agree to use condoms and refrain from donating sperm for the course of the trial through 120 days after the last dose of trial medication
Where can I participate?
CS Cancer at The Angeles Clinic and Research Institute : Crystal Ducharme
More about this Clinical Trial
What is the full name of this clinical trial?
TV56278-ONC-10203: A Phase 1a/1b Open-Label, Multicenter, Dose Escalation, and Dose Expansion Trial to Evaluate the Safety and Activity of TEV-56278, as a Monotherapy and in Combination with Pembrolizumab in Participants with Selected Locally Advanced or Metastatic Solid Tumors