NCT06090266 A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents
| NCT ID | NCT06090266 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | OncoResponse, Inc. |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2023-10-24 |
| Primary Completion | 2026-08-01 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Informed consent signed by the subject prior to conducting study-specific procedures. 2. Male or female subjects ≥ 18 years of age. 3. Histological diagnosis as follows: 1. 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. 2. 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. 4. Prior therapies: a. Part A (dose-escalation) and Cohort B1 (monotherapy expansion) i. Subjects must have experienced progressive disease (PD) on an established standard systemic anti-cancer therapy for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible f
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