Study of Axatilimab with Retifanlimab and Paclitaxel to Treat Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, side effects, and effectiveness of combining axatilimab, retifanlimab, and paclitaxel to treat patients with advanced or metastatic solid tumors. This phase III trial focuses on tumors that have spread from the original site to nearby tissues, lymph nodes, or distant parts of the body. Axatilimab is a monoclonal antibody that may inhibit tumor growth and spread, retifanlimab is an immunotherapy that helps the immune system attack cancer, and paclitaxel is a medication that stops cancer cells from growing and dividing. Participants receive axatilimab intravenously over 30 minutes on day -8 before cycle 1. Starting cycle 1 day 1, axatilimab is given on days 8 and 22, retifanlimab on day 1, and paclitaxel on days 1, 8, and 15 of each 28-day cycle. Treatment cycles repeat every 28 days unless disease progresses or unacceptable side effects occur. Patients undergo tumor biopsies, CT scans, and blood sample collections during the study, with optional MRI and PET scans. During participation, patients will be monitored for safety, side effects, and clinical benefit, including dose-limiting toxicities and immune response changes. Follow-up visits occur at 30 and 90 days after treatment completion. The study measures tumor response, immune cell changes, and treatment tolerability over about six months. All procedures and assessments aim to understand the combinations impact on tumor growth and patient health.

Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors