A Multicenter, Open-label, Proof of Concept Phase II Aiming to Assess the Clinical and Biological Activity of Anti-netrin-1 (NP137) as Add on Therapy in Patients With Advanced/Metastatic Solid Tumors Treated by Standard Immunotherapies

• Status: Not yet recruiting
• Trial end date: 2026-11-24

Summary

This study is a multicenter, open-label, proof-of-concept study aiming to assess the clinical and biological impact of NP137 when added to standard PD-1/PD-L1 blockade therapy in 3 independent cohorts of advanced or metastatic solid tumors with various sensitivity to anti-PD-1/PD-L1:

• Cohort 1 [Stable Disease]: Patients with a radiological documentation of SD according to RECIST V1.1 criteria following at least 12 weeks under standard anti PD-1/PD-L1 therapy. The initial evidence of SD is to be confirmed by a second assessment, no less than 4 weeks from the date of the first documented SD.

• Cohort 2 [primary refractory]: Patients with documented radiological PD according to RECIST V1.1 but with clinical benefit under anti PD-1/PD-L1 standard therapy.

• Cohort 3 [secondary refractory]: Patients with documented radiological PD following an initial Objective Response according to RECIST V1.1, with clinical benefit under standard anti-PD-1/PD-L1.

• Phase: Phase 2

Details

• Lead Sponsor: Centre Leon Berard
• Collaborator: NETRIS Pharma