This is an open-label, multicenter, first-in-human dose-escalation and expansion Phase 1-2 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR502 administered as a monotherapy and in combination with cemiplimab in subjects with advanced solid tumors.
Informed consent signed by the subject prior to conducting study-specific procedures.
Male or female subjects ≥ 18 years of age.
Parts A and B (Cohorts A1, A2, and B1): subjects must have a histological diagnosis of any type of carcinoma, sarcoma, or melanoma with progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy with curative intent.
Part B (Expansion Cohorts B2-B3): subjects must have a histological diagnosis of the relevant tumor type (CSCC or PROC) with advanced/metastatic disease not amenable to local therapy with curative intent.
Subject previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb).
Life expectancy < 12 weeks.
Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) > 2.
Prior organ or stem cell transplant.