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A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Prodrug Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours

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Trial Profile

A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Prodrug Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 12 Mar 2025

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At a glance

  • Drugs AVA 6000 (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Biliary cancer; Bladder cancer; Colorectal cancer; Head and neck cancer; Liposarcoma; Malignant fibrous histiocytoma; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Prostate cancer; Salivary gland cancer; Soft tissue sarcoma; Solid tumours; Squamous cell cancer; Triple negative breast cancer
  • Focus Adverse reactions; First in man
  • Sponsors Avacta

    • Most Recent Events

    • 07 Mar 2025 According to an Avacta media release, the company anticipates providing a further update from the Phase 1a dose escalation data in 2Q 2025 and Phase 1b dose expansion cohort data at the end of 2025. The full Phase 1a data will be presented in 2H 2025, including a full assessment of the cardiac safety data with long-term follow up. The data will allow the Company to plan for the registration study of AVA6000.
    • 07 Mar 2025 According to an Avacta media release, the company announced that the lead program of the Company, AVA6000, has completed the Phase 1a dose escalation with encouraging PFS data in patients with salivary gland cancers and initiated enrollment and dosing in the Phase 1b expansion cohorts with multiple patients treated.
    • 07 Mar 2025 Results presented in an Avacta Media Release.

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