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A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCnyeso, an HLA- A*0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, as a Single Agent in HLA-A*0201 Positive Patients with Advanced NY-ESO-1 and/or LAGE-1A Positive Cancer
IMCnyeso is a new biological therapy designed for the treatment of cancers which express NY-ESO-1 and/or LAGE-1A. This is a first-in-human trial designed to evaluate the safety and efficacy of IMCnyeso in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for NY-ESO-1 and/or LAGE-A1.
Phase I Dose Escalation Cohorts: The primary objective of Phase I is to identify the MTD and/or the RP2D of IMCnyeso, as a monotherapy, when administered weekly to patients with advanced NSCLC, melanoma, urothelial cancer, and synovial sarcoma. Phase II Dose Expansion Cohorts: The primary objective of Phase II is to further explore the safety and tolerability of the identified RP2D of IMCnyeso in 3 patient populations: advanced NSCLC, urothelial cancer, and synovial sarcoma.