Phase 1/2 N17350 intratumoral ELANE-pathway therapeutic elastase (recombinant mutant elastase)

This Phase 1/2 open-label, dose-finding and expansion study (OP-NEU-101) tests intratumoral N17350 injections every 2 weeks (typically up to 12 weeks) in adults with advanced/metastatic solid tumors that have progressed after available therapies or where no standard option exists. N17350 (Onchilles Pharma) is a tumor-directed therapeutic elastase designed to leverage the neutrophil elastase (ELANE) pathway—aiming to selectively kill cancer cells locally while preserving immune cells and potentially stimulating systemic anti-tumor immunity. The Phase 1 portion escalates concentration/dose across superficial and visceral injectable lesions to define safety, tolerability, and a recommended Phase 2 dose, with pharmacokinetics, imaging-based response, and immune/tumor sampling. Phase 2 expansion cohorts include cutaneous squamous cell carcinoma, melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and triple-negative breast cancer, each representing settings where patients commonly cycle through sequential systemic options (immunotherapy when eligible, targeted therapy for actionable drivers, chemotherapy, and later-line antibody-drug conjugates in some diseases), and where a local, repeatable intratumoral biologic could offer a complementary mechanism.