Phase 1 Study of AP601 Safety and Effects in Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are investigating the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of AP601, a fully human bispecific antibody, in patients with locally unresectable advanced or metastatic solid tumors who have not responded to standard treatments or have refused them. This Phase 1, open-label study aims to find the highest safe dose of AP601 for these patients by testing increasing doses across multiple groups. Participants will receive AP601 intravenously as a single infusion every two weeks for up to 12 months. The study has two parts a dose escalation phase where up to six different dose levels ranging from 0.5 mgkg to 10 mgkg are evaluated using a 33 design to monitor for dose-limiting toxicities, and a possible dose expansion phase after completion of dose escalation. Infusion times are approximately 60 to 120 minutes. Throughout the study, participants will undergo regular assessments including safety monitoring for adverse events, laboratory tests, vital sign measurements, electrocardiograms, and tumor evaluations using RECIST criteria. Pharmacokinetics and immunogenicity of AP601 will be measured at multiple time points during treatment. The primary outcome focuses on determining the maximum tolerated dose and recommended phase 2 dose, with ongoing safety follow-up up to 90 days after the last dose and extended evaluations of antitumor activity and clinical benefit up to two years.

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