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

NCT05605496 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • NETRIS Pharma

    collaborator INDUSTRY

  • Centre Leon Berard

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-06
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05605496 on ClinicalTrials.gov