nctId: NCT06311214 id: NCI-2024-01903 id: NCI-2024-01903 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 10397 type: OTHER domain: University of Texas MD Anderson Cancer Center LAO id: 10397 type: OTHER domain: CTEP id: UM1CA186688 type: NIH link: https://reporter.nih.gov/quickSearch/UM1CA186688 briefTitle: 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) overallStatus: NOT_YET_RECRUITING date: 2024-06-21 date: 2024-10-31 date: 2024-10-31 date: 2024-03-15 date: 2024-03-15 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II ADC MATCH screening and multi-sub-study treatment trial is evaluating whether biomarker-directed treatment with one of three antibody-drug conjugates (ADCs) (sacituzumab govitecan, enfortumab vedotin, and trastuzumab deruxtecan) works in treating patients with solid tumor cancers that have high expression of the Trop-2, nectin-4, or HER2 proteins and that may have spread from where they first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or to other places in the body (metastatic). Precision medicine is a form of medicine that uses information about a person's genes, proteins, and environment to prevent, diagnose, or treat disease in a way that is tailored to the patient. ADCs such as sacituzumab govitecan, enfortumab vedotin, and trastuzumab deruxtecan are monoclonal antibodies attached to biologically active drugs and are a form of targeted therapy. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a drug called govitecan. Sacituzumab attaches to a protein called Trop-2 on the surface of tumor cells and delivers govitecan to kill them. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. Trastuzumab deruxtecan is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Personalized treatment with sacituzumab govitecan, enfortumab vedotin, or trastuzumab deruxtecan may be an effective treatment option for patients with advanced or metastatic solid tumors that screen positive for high expression of Trop-2, nectin-4, or HER2, respectively. conditions: Advanced Malignant Solid Neoplasm conditions: Metastatic Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Echocardiography name: Electronic Health Record Review name: Enfortumab Vedotin name: Immunohistochemistry Staining Method name: Magnetic Resonance Imaging name: Multigated Acquisition Scan name: Sacituzumab Govitecan name: Trastuzumab Deruxtecan measure: Frequency of high protein expression in patients with high ribonucleic acid (RNA) expression of each antibody-drug conjugate target (screening protocol) measure: Objective response rate (treatment cohorts) measure: Frequency that patients with high RNA and immunohistochemistry target expression receive cohort treatment on study (screening protocol) measure: Progression free survival (treatment cohorts) measure: Overall survival (treatment cohorts) measure: Time to progression (treatment cohorts) measure: Incidence of adverse events (treatment cohorts) measure: RNA expression of targets of interest (TOIs) (treatment cohorts) measure: Temporal tumor heterogeneity (treatment cohorts) measure: Potential predictive biomarkers and other molecular features (treatment cohorts) measure: Pharmacodynamic changes in the tumor and microenvironment (treatment cohorts) measure: Mechanisms of acquired resistance (treatment cohorts) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False