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A randomized non-comparative open-label phase 1b/2 study of nadunolimab in combination with gemcitabine plus carboplatin in patients with advanced triple negative breast cancer (TRIFOUR)

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Trial Profile

A randomized non-comparative open-label phase 1b/2 study of nadunolimab in combination with gemcitabine plus carboplatin in patients with advanced triple negative breast cancer (TRIFOUR)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 17 Apr 2024

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At a glance

  • Drugs Carboplatin (Primary) ; Gemcitabine (Primary) ; Nadunolimab (Primary)
  • Indications Advanced breast cancer; Triple negative breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms TRIFOUR
  • Sponsors Cantargia
  • Most Recent Events

    • 24 Oct 2023 Results assessing the preliminary safety and efficacy of nadunolimab/gemcitabine/carboplatin from the phase 1b dose-escalation in metastatic TNBC, presented at the 48th European Society for Medical Oncology Congress.
    • 14 Mar 2023 According to a Cantargia media release, the first triple-negative breast cancer (TNBC) patient has initiated treatment with the IL1RAP-binding antibody nadunolimab (CAN04) and chemotherapy in the phase II randomized part of the trial. Up to 98 patients may be included in this part and the next milestone, an interim futility analysis will be carried for 28 patients.
    • 23 Feb 2023 According to a Cantargia media release, Dr.Agostina Stradella, medical oncologist, member of GEICAM at Catalan Institute of Oncology, Duran i Reynals Hospital is the Principal Investigator of this trial.
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