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Dose Escalation, First-in-human Clinical Trial to Evaluate the Safety, Pharmacokinetics and Preliminary Antitumor Activity of PEP-010, Administered as Single Agent and in Combination With Paclitaxel in Patients With Metastatic Solid Cancer

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Trial Profile

Dose Escalation, First-in-human Clinical Trial to Evaluate the Safety, Pharmacokinetics and Preliminary Antitumor Activity of PEP-010, Administered as Single Agent and in Combination With Paclitaxel in Patients With Metastatic Solid Cancer

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 30 Apr 2024

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At a glance

  • Drugs Gemcitabine (Primary) ; Paclitaxel (Primary) ; PEP 010 (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Male breast cancer; Ovarian cancer; Pancreatic cancer; Solid tumours; Triple negative breast cancer
  • Focus Adverse reactions; First in man
  • Acronyms CleverPeptide

    • Most Recent Events

    • 25 Apr 2024 According to a PEP-Therapy media release, company announced the dosing of the first patients in a Phase Ib clinical trial of PEP-010 in combination with chemotherapy (paclitaxel or gemcitabine), in advanced or metastatic ovarian cancer (OC) and in metastatic pancreatic ductal adenocarcinoma (PDAC), two indications with high unmet medical need. Four sites in France are currently recruiting: Institut Curie, Gustave Roussy, Centre Francois Baclesse and Institut de Cancerologie de lOuest.
    • 15 Dec 2023 Planned number of patients changed from 56 to 87.
    • 15 Dec 2023 Planned End Date changed from 31 Dec 2023 to 31 Dec 2024.

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