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A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors

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Trial Profile

A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors

Status: Completed
Phase of Trial: Phase 0

Latest Information Update: 28 Aug 2025

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At a glance

  • Drugs PBA 0405 (Primary)
  • Indications Advanced breast cancer; Alveolar soft part sarcoma; Early breast cancer; Fibrosarcoma; Haemangiosarcoma; Head and neck cancer; Male breast cancer; Malignant fibrous histiocytoma; Sarcoma; Skin cancer; Soft tissue sarcoma; Solid tumours; Squamous cell cancer; Synovial sarcoma; Triple negative breast cancer
  • Focus Biomarker; Pharmacodynamics
  • Sponsors Pure Biologics

Most Recent Events

  • 11 Aug 2025 Status changed from recruiting to completed.
  • 21 Nov 2024 According to a Pure Biologics media release, this study is expected to conclude in H1 2024. Prior to that, the Company expects partial results as the study progresses.
  • 21 Nov 2024 According to a Pure Biologics media release, company has applied to the U.S. Food and Drug Administration (FDA) for approval to test molecule PBA-0405 (exploratory Investigational New Drug; eIND), the lead candidate in project PB004 in a Phase 0 clinical trial in patients with solid tumors.

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