Phase 12 Study of OR502 Antibody Alone and With Cemiplimab for Advanced Solid Tumors and Specific Cancers

What this Trial Is About

Researchers are evaluating OR502, a monoclonal antibody targeting LILRB2, alone and in combination with cemiplimab in people with advanced solid tumors. This open-label, early-phase study aims to assess the safety, tolerability, how the body processes the drugs, and preliminary anti-tumor effects in adults with various advanced cancers. The study is part of a Phase 1-2 trial involving multiple centers and includes patients with different tumor types, including ovarian cancer, cutaneous squamous cell carcinoma, melanoma, and non-small cell lung cancer. The study has several parts Part A involves dose escalation of OR502 alone or combined with cemiplimab, both given intravenously every three weeks, to find the optimal dose. Part B includes expansion cohorts where participants receive OR502 at two dose levels as monotherapy or with cemiplimab, targeting specific cancers such as platinum-resistant ovarian cancer and cutaneous squamous cell carcinoma. Additional mini-expansion cohorts treat melanoma and non-small cell lung cancer patients who previously received PD-L1 inhibitor therapies. Cemiplimab is administered as an IV infusion at a fixed dose of 350 mg. Participants will undergo regular assessments including monitoring for dose-limiting toxicities, adverse events, vital signs, and organ function from screening through 90 days post-treatment. Researchers will measure pharmacokinetics, tumor response rates, disease control, and progression-free survival. Tissue biopsies for biomarker analysis may be requested but are optional except for certain cohorts. The total study duration varies by participant, with continuous monitoring during treatment and follow-up phases to evaluate safety and preliminary effectiveness.

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