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A Phase 1, Open-Label, Dose Finding Study of NI-1801, a Bispecific Mesothelin X CD47 Engaging Antibody, As a Single Agent, in Combination with Anti-PD-1 Antibody, and in Combination with Weekly Paclitaxel (Standard of Care) in Patients with Mesothelin Expressing Ovarian, Pancreatic, Non-Small-Cell-Lung and Triple-Negative Breast Cancers

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Trial Profile

A Phase 1, Open-Label, Dose Finding Study of NI-1801, a Bispecific Mesothelin X CD47 Engaging Antibody, As a Single Agent, in Combination with Anti-PD-1 Antibody, and in Combination with Weekly Paclitaxel (Standard of Care) in Patients with Mesothelin Expressing Ovarian, Pancreatic, Non-Small-Cell-Lung and Triple-Negative Breast Cancers

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 31 Oct 2024

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At a glance

  • Drugs NI-1801 (Primary) ; Pembrolizumab (Primary) ; Paclitaxel
  • Indications Advanced breast cancer; Carcinoma; Male breast cancer; Non-small cell lung cancer; Ovarian cancer; Triple negative breast cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Light Chain Bioscience

    • Most Recent Events

    • 19 Oct 2024 According to ClinicalTrials.gov record, protocol has been amended to increase study arms from 1 to 3, to include combination arm of NI-1801 in combination with anti-PD1 (Pembrolizumab) and paclitaxel. Patient number increased to 70.
    • 19 Sep 2024 Planned number of patients changed from 40 to 70.
    • 19 Sep 2024 Planned End Date changed from 30 Sep 2025 to 30 Sep 2026.

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