drugset / Trial / NCT06022029

A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.

NCT06022029

Phase 1 Recruiting 168 enrolled OncoNano Medicine, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

A phase 1, multicenter, open label, non-randomized dose escalation and dose expansion study to examine the maximum tolerated dose, (MTD), minimum effective dose (MED) and/or recommended dose for expansion (RDE) of intratumoral ONM-501 as monotherapy and in combination with a PD-1 checkpoint inhibitor in patients with advanced solid tumors and lymphomas.

Timeline

Start
2023-10-13
Primary completion
2026-04-30
Completion
2026-08-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Cemiplimab Monoclonal antibody 350 mg Intravenous
Subject ONM-501 Unknown Other