NCT06090266

A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents

A Phase 1/2 Study of OR502 Alone and in Combination With Other Anti-cancer Agents in Subjects With Advanced Malignancies

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: OncoResponse, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Phase 1-2 study is designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR502, a fully human IgG1 antibody that binds specifically to LILRB2, in subjects with advanced solid tumors. The study consists parts: Part A: a dose-escalation phase to determine the maximum-tolerated dose (MTD), maximum achievable dose, or optimal dose of OR502 for further evaluation as monotherapy and in combination with cemiplimab in a maximum of approximately 48 subjects. Recruitment closed. Part B: an expansion phase in subjects with advanced solid tumors treated with OR502 at 2 separate doses as monotherapy followed by combination with cemiplimab, and in subjects with previously treated platinum-resistant ovarian cancer (PROC) or cutaneous squamous cell carcinoma (CSCC) treated with OR502 at 2 separate doses in combination with cemiplimab. Up to approximately 20 subjects will be treated in each arm of the 3 Part B cohorts to further characterize safety, help determine the recommended Phase 2 dose (RP2D) for further development and determine preliminary anti-tumor activity. Up to approximately 120 subjects total will be treated in Part B. Not yet open. Part B4: a mini-expansion cohort in subjects with a histological diagnosis of cutaneous melanoma with advanced/metastatic disease. Subjects must have received a PD-(L)1 inhibitor-based therapy, either alone or in combination with other anti-cancer agents, for at least 12 weeks. Subjects in this cohort will be treated with OR502 as monotherapy. Actively recruiting. Part B5: a mini-expansion cohort in subjects with a histological diagnosis of non-small cell lung cancer (NSCLC) with advanced/metastatic disease. Subjects must have received a PD-(L)1 inhibitor-based therapy, either alone or in combination with other anti-cancer agents, for at least 12 weeks. Subjects in this cohort will be treated with OR502 in combination with cemiplimab. Actively recruiting.

Conditions

• Cancer
• Tumor, Solid
• Malignant Neoplasm
• Metastatic Cancer
• Advanced Solid Tumor
• Cutaneous Melanoma
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	OR502	IgG1 monoclonal antibody that binds specifically to the LILRB2 protein.
DRUG	Cemiplimab	IgG4 mAb that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2.

Timeline

• Start date: 2023-10-24
• Primary completion: 2026-08-01
• Completion: 2027-02-01
• First posted: 2023-10-19
• Last updated: 2025-01-07

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study