Clinical Trial

A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors

Recruiting Phase 1
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Summary
A Phase 1, Open-Label Study of the Safety, Tolerability,Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP601 in Patients with Solid Tumours.The study is designed to find the highest dose of AP601 that can be given safely. Participants will be assigned to one of six cohorts. Each cohort will receive a different dose of the study medication, AP601, based on the body weight. Each cohort will initially enrol 1-3 participants. If no serious side effects are seen in the first participant(s), the next cohort will receive the next dose level.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-02.
Status change: Not Yet Recruiting → Recruiting 2025-12-22
Trial Details
NCT Number NCT07165067
Lead Sponsor AP Biosciences Inc.
Collaborators: Avance Clinical Pty Ltd.
Conditions Solid Tumours
Enrollment 36 participants
Start Date 2026-01-21
Primary Completion 2027-12-27 (estimated)
Study Completion 2028-01-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-29