drugset / Trial / NCT07165067
A Study of AP601 in Patients With Locally Unresectable Advanced or Metastatic Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2026-01-21
- Primary completion
- 2027-12-27
- Completion
- 2028-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AP601 | Unknown | 0.5 mg/kg | Intravenous |
| Subject | AP601 | Unknown | 1.25 mg/kg | Intravenous |
| Subject | AP601 | Unknown | 2.5 mg/kg | Intravenous |
| Subject | AP601 | Unknown | 5 mg/kg | Intravenous |
| Subject | AP601 | Unknown | 7.5 mg/kg | Intravenous |
| Subject | AP601 | Unknown | 10 mg/kg | Intravenous |