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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

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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: 09 Mar 2025

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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; Triple negative breast cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
  • Acronyms Duravelo-1
  • Sponsors Bicycle Therapeutics

    • Most Recent Events

    • 25 Feb 2025 According to a Bicycle Therapeutics media release, based on the data from this study the USFDA has granted Fast Track designation to zelenectide pevedotin for the treatment of adult patients with previously treated, NECTIN4 gene-amplified, advanced or metastatic TNBC and NSCLC.
    • 13 Jan 2025 According to a Bicycle Therapeutics media release, additional Phase 1 Duravelo-1 combination data with pembrolizumab in first-line cisplatin-ineligible mUC expected in 2H 2025. Longer term follow-up Phase 1 Duravelo-1 monotherapy data in late-line mUC in 2H 2025.
    • 13 Jan 2025 According to a Bicycle Therapeutics media release, company reported monotherapy data for zelenectide pevedotin showing an enhanced response in late-line breast cancer and non-small cell lung cancer (NSCLC) patients with NECTIN4 gene amplification and/or polysomy.

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