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A Phase 1, Open-Label, Multicenter, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of APR-1051 in Patients With Advanced Solid Tumors

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Trial Profile

A Phase 1, Open-Label, Multicenter, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of APR-1051 in Patients With Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 12 Jul 2025

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At a glance

  • Drugs ATRN 1051 (Primary)
  • Indications Advanced breast cancer; Carcinoma; Colorectal cancer; Head and neck cancer; Oropharyngeal cancer; Ovarian cancer; Pancreatic cancer; Prostate cancer; Solid tumours; Squamous cell cancer; Uterine cancer
  • Focus Adverse reactions; First in man
  • Acronyms ACESOT-1051
  • Sponsors Aprea Therapeutics

Most Recent Events

  • 25 Jun 2025 According to an Aprea Therapeutics media release, enrolment in this study is progressing, and when additional data comes up, future trial arms may evaluate APR-1051 in combination with checkpoint inhibitors.
  • 25 Jun 2025 According to an Aprea Therapeutics media release, initial update from this study shows early disease control in first HPV+ patient, a 62-year-old male with advanced HPV-positive oropharyngeal squamous cell carcinoma who had progressed after 3 prior lines of platinum-based therapy, treated with APR-1051.
  • 31 Mar 2025 According to an Aprea Therapeutics media release, company announced that a patient with HPV+ head and neck squamous cell carcinoma (HNSCC) has been dosed in this study.

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