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A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid Tumors

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Trial Profile

A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid Tumors

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 13 Mar 2024

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At a glance

  • Drugs Nanrilkefusp alfa (Primary) ; Pembrolizumab (Primary)
  • Indications Advanced breast cancer; Anal cancer; Biliary cancer; Bladder cancer; Carcinoma; Cervical cancer; Colorectal cancer; Gastric cancer; Head and neck cancer; Liver cancer; Malignant melanoma; Malignant thymoma; Merkel cell carcinoma; Mesothelioma; Non-small cell lung cancer; Ovarian cancer; Renal cell carcinoma; Skin cancer; Small cell lung cancer; Solid tumours; Squamous cell cancer; Thyroid cancer
  • Focus Adverse reactions; First in man
  • Acronyms AURELIO-03
  • Sponsors SOTIO

    • Most Recent Events

    • 06 Mar 2024 Planned End Date changed from 1 Dec 2023 to 1 Nov 2024.
    • 06 Mar 2024 Planned primary completion date changed from 1 Dec 2023 to 1 Aug 2024.
    • 13 Oct 2023 According to a SOTIO media release, trials of nanrilkefusp alfa will be discontinued due to insufficient efficacy. Based upon the interim data, effective immediately, enrollment in the AURELIO-03, AURELIO-04, and AURELIO-05 clinical trials will be stopped. SOTIO will continue to fulfill its obligations to patients currently enrolled in these trials, who will be able to continue treatment under the current protocol at the discretion of their principal investigator.
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