Personalized Treatment with Targeted Antibody-Drug Conjugates for Advanced or Metastatic Solid Tumors Based on RNA and Protein Testing

What this Trial Is About

Researchers are evaluating a phase II trial to study the use of personalized antibody-drug conjugates ADCs for treating patients with advanced or metastatic solid tumors that show high protein expression of Trop-2, nectin-4, or HER2. This trial aims to assess whether targeted treatments with sacituzumab govitecan, enfortumab vedotin, or trastuzumab deruxtecan work based on RNA and protein testing of tumor markers. These ADCs combine monoclonal antibodies with active drugs to target cancer cells more precisely. The study includes a two-step screening process. First, patients existing RNA test results are reviewed for expression of targets of interest TOIs. Then, protein expression is confirmed by immunohistochemistry IHC on previously collected tissue. Patients with high expression are assigned to one of three treatment cohorts receiving the corresponding ADC drug intravenously on specific schedules sacituzumab govitecan on days 1 and 8 every 21 days enfortumab vedotin on days 1, 8, and 15 every 28 days and trastuzumab deruxtecan on day 1 every 21 days. Imaging scans, biopsies, and blood sample collections are performed throughout the trial, with optional samples taken at progression. Echocardiography or MUGA scans are also used for patients receiving trastuzumab deruxtecan. Participants will undergo thorough assessments including CT and MRI imaging, tumor biopsies before and during treatment, blood collections, and heart function monitoring as applicable. Researchers will measure tumor response rates, progression-free survival, overall survival, molecular markers, and adverse events. After treatment ends, patients will be followed for up to three years with regular check-ins every 3 to 6 months to monitor outcomes and safety. This comprehensive monitoring helps understand the therapys impact and tumor changes over time.

Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial)