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.
Parallel
OR502
DrugIgG1 monoclonal antibody that binds specifically to the LILRB2 protein.
Cemiplimab
DrugIgG4 mAb that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2.
Dose-limiting Toxicity
The incidence of DLTs during the DLT assessment period.
Adverse Events and Serious Adverse Events
The nature, frequency, and severity of adverse events and serious adverse events graded by CTCAE v 5.0 as aggregated descriptive findings.
Vital Signs
Assessment of changes in vital sign measurements (heart rate, pulse oximetry and blood pressure) as aggregated descriptive findings.
Recommended Dose and Regimen (mono and combination therapy)
Determination of the recommended dose of OR502 for further development.
Pharmacokinetics of OR502
Peak plasma concentration (Cmax).
Pharmacokinetics of OR502
Area under the plasma concentration versus time curve (AUC).
Objective Response Rate (ORR)
ORR according to RECIST v1.1.
Disease Control Rate (DCR)
The percentage of subjects with a complete response, partial response, or stable disease for at least 2 consecutive tumor assessments.
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