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Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies

Trial Profile

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 27 Apr 2026

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At a glance

  • Drugs Pembrolizumab (Primary) ; Zelenectide pevedotin (Primary)
  • Indications Advanced breast cancer; Bladder cancer; Carcinoma; Fallopian tube cancer; Gastric cancer; Head and neck cancer; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Peritoneal cancer; Solid tumours; Transitional cell carcinoma; Triple negative breast cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
  • Acronyms Duravelo-1
  • Sponsors Bicycle Therapeutics

Most Recent Events

  • 21 Apr 2026 According to Bicycle Therapeutics media release, updated data from this study will be presented at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting, taking place May 29-June 2 in Chicago.
  • 12 Jan 2026 According to Bicycle Therapeutics media release, the company plans to present additional data at a scientific conference and longer-term follow-up Phase 1 Duravelo-1 monotherapy data in the first half of 2026.
  • 01 May 2025 According to Bicycle Therapeutics media release, company will present data from this study as a poster presentation at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting.

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