A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents
NCT06090266 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 168
Last updated 2025-01-07
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.
Conditions
- Cancer
- Tumor, Solid
- Malignant Neoplasm
- Metastatic Cancer
- Advanced Solid Tumor
- Cutaneous Melanoma
- Non-small Cell Lung Cancer
Interventions
- DRUG
-
OR502
IgG1 monoclonal antibody that binds specifically to the LILRB2 protein.
- DRUG
-
IgG4 mAb that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2.
Sponsors & Collaborators
-
OncoResponse, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-24
- Primary Completion
- 2026-08-01
- Completion
- 2027-02-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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