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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

Study acronym: IMMUNONET
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Interventions: NP137 (Drug), anti-PD-1/PD-L1 (Drug) to NP137 (Drug), anti-PD-1/PD-L1 (Drug)
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description expanded, about 7 words
  2. Primary completion pushed from Feb 24, 2026 to Jan 1, 2027
    • Study completion pushed from Nov 24, 2026 to Jan 1, 2027
    v11
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 87 to confirmed 57
    • Site details revised at 5 of 5 sites
    v10
  4. Eligibility criteria expanded, about 39 words
    • Site contacts updated at 5 of 5 sites
    v9
  5. Site contacts updated at 5 of 5 sitesv8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 4 to 5
    • Eligibility criteria expanded, about 158 words
    v7
  2. Study sites: 1 to 4
    • Eligibility criteria expanded, about 45 words
    v6
  3. Start date changed from estimate of Nov 24, 2022 to Jan 6, 2023v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
  5. Study title revisedv3
  6. Study title shortened, about 15 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05605496
Lead Sponsor Centre Leon Berard
Collaborators: NETRIS Pharma
Conditions
(from sponsor)		 Advanced Solid Tumors, Metastatic Solid Tumors
Enrollment 57 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov