NCT05605496

NP137 Clinical and Biological Activities Assessment in Patients With Advanced/Metastatic Solid Tumors Treated by Standard Anti PD-1/PD-L1 Immunotherapies

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: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. Note: This treatment arm closed on 27/09/2024 due to non-feasibility. * Cohort 2 \[primary refractory\]: Patients with documented radiological PD or short-term SD (\< 6months) according to RECIST V1.1 but with clinical benefit under PD-1/PD-L1 standard therapy. * Cohort 3 \[secondary refractory\]: Patients with documented radiological PD following an initial Objective Response or long-term SD (i.e. ≥6 months) according to RECIST V1.1, with clinical benefit under standard PD-1/PD-L1.

Detailed description

To be eligible to cohort 1 \[stable disease\], 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. To be eligible to cohorts 2 and 3 \[primary and secondary refractory patients\], patients must meet all the following criteria: * Evidence of clinical benefit according to investigator assessment. The assessment of clinical benefit should be balanced by clinical judgment as to whether the patient is clinically deteriorating and unlikely to receive any benefit from continued anti-PD-1/PD-L1 treatment. * Absence of symptoms and signs (including laboratory values, such as new or worsening hypercalcemia) indicating unequivocal progression of disease, * Absence of decline in ECOG PS that can be attributed to disease progression, * Absence of tumor progression at critical anatomical sites (e.g., leptomeningeal disease) that cannot be managed by protocol-allowed medical interventions. * No ongoing clinically significant AE related to anti-PD-1/PD-L1. During this study: * All patients will receive NP137 (14 mg/kg, IV, Q3W) as add-on treatment to their standard anti-PD1 or anti-PDL1 treatment administered. * To facilitate the study treatments administration and to not over burden patients, the study drug NP137 which is administered every 3 weeks (Q3W) will be associated to standard PD-1/PD-L1 therapies for which dosing are administered every 3 weeks or every 6 weeks (Q3W or Q6W). A treatment delay of up to 3 days is allowed before the start of a new cycle.

Conditions

• Advanced Solid Tumors
• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	NP137	IV infusion, 14mg/kg, Q3W
DRUG	anti-PD-1/PD-L1	IV infusion, Q3W or Q6W anti-PD1/PDL1 are standard treatments and are prepared and administred as per respective SmPC and institutional practice.

Timeline

• Start date: 2023-01-06
• Primary completion: 2026-02-24
• Completion: 2026-11-24
• First posted: 2022-11-04
• Last updated: 2026-02-10

Locations

5 sites across 1 country: France