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Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression

Trial Profile

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 Mar 2025

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At a glance

  • Drugs BT 5528 (Primary) ; Nivolumab (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Bladder cancer; Gastric cancer; Gastrointestinal cancer; Head and neck cancer; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Solid tumours; Triple negative breast cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Bicycle Therapeutics
  • Most Recent Events

    • 25 Feb 2025 According to a Bicycle Therapeutics media release, initial EphA2 human imaging data expected in 2H 2025.
    • 13 Jan 2025 According to a Bicycle Therapeutics media release, company to report combination data for BT5528 plus nivolumab in 4Q 2025.
    • 22 Nov 2024 Planned End Date changed from 1 Oct 2026 to 1 Oct 2025.

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