A PHASE 1/2 STUDY OF REGN5678 (ANTI-PSMAXCD28) WITH CEMIPLIMAB (ANTI-PD-1) IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER [Regeneron 5678-ONC-1879]

Brief description of study

The purpose of the trial is to determine safety and tolerability of REGN5678 alone and in combination with cemiplimab in treatment-experienced metastatic castration-resistant prostate cancer (mCRPC). REGN5678 is a bi-specific antibody that engages the co-stimulatory receptor CD28 and the prostate cancer membrane protein PSMA in order to bring cancer-specific T cells to the tumor. Cemiplimab is a potent fully human mAb that binds to PD-1 and blocks PD-1/PD-L1-mediated inhibitory signaling in helper and cytotoxic T cells, thus rescuing the anti-tumor immune response. The study drugs REGN5678 and Cemiplimab are investigational, which means that they have not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test these agents in the current trial.


Clinical Study Identifier: s19-00246
ClinicalTrials.gov Identifier: NCT03972657
Principal Investigator: David R. Wise.
Other Investigators: Victor Ricardo Adorno Febles, Minas Platon Economides, Scot Niglio, Arielle M. Kurzweil, Elcin Zan, Hank Ng.


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