Intrathecal Application of PD1 Antibody in Metastatic Solid Tumors With Leptomeningeal Disease (IT-PD1/ NOA 26)

Phase 1 Recruiting 46 enrolled University Hospital Tuebingen

NaSequentialOpen-labelTreatment

Summary

To determine the safety of intrathecal (IT) PD1 antibody for Intrathecal application of PD1 antibody in metastatic solid tumors with leptomeningeal disease of solid tumors.

Timeline

Start: 2021-10-12
Primary completion: 2026-12-31
Completion: 2027-09-30

Outcome

Met primary endpoint

paper The primary endpoint was met and the recommended fixed dose for the ongoing expansion part is 50 mg. PMID 42243276 ↗

Publications

Tabatabai G, Ramirez I, Welte B, Bombach P, Becker H, Bernhardt D, Mayer-Steinacker R, Meier F, Neidert N, Roelz R, Mildenberger I, Bunse L, Platten M, Herrlinger U, Martens UM, Ernemann U, Neumann M, Tatagiba M, Serna-Higuita LM, Martus P, Renovanz M. Intrathecal nivolumab in metastatic solid tumors with leptomeningeal disease: dose escalation part of the multicenter IT-PD1/NOA-26 phase 1 trial. Nat Cancer. 2026 Jun 4. doi: 10.1038/s43018-026-01185-4. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	20 mg	Intrathecal
Subject	Nivolumab	Monoclonal antibody	30 mg	Intrathecal
Subject	Nivolumab	Monoclonal antibody	40 mg	Intrathecal
Subject	Nivolumab	Monoclonal antibody	50 mg	Intrathecal