Phase 12 Study of AP203 Safety, Activity, and How the Body Processes It in Adults with Advanced or Metastatic Solid Tumors including Lung, Head and Neck, or Esophageal Cancers

What this Trial Is About

Researchers are evaluating AP203, a drug being studied in adults with locally advanced or metastatic solid tumors, including specific cancers like non-small cell lung cancer NSCLC, head and neck squamous cell carcinoma HNSCC, and esophageal squamous cell carcinoma ESCC. This open-label study involves two phases dose escalation to find safe dose levels, and dose expansion to further assess the drug in selected tumor types. The goal is to understand the safety, how the drug moves through and affects the body, immune responses, and anti-tumor effects. Participants receive AP203 through intravenous infusion. In the dose escalation phase, eight dose levels from 0.00064 to 20 mgkg are tested weekly for the first 3 weeks, then every 2 weeks afterward to find the maximum tolerated or recommended phase 2 dose. The dose expansion phase follows, giving participants the recommended dose on the same schedule to study its effect in specific cancers. The study is non-randomized and open-label, meaning both patients and researchers know the treatment given. During the study, participants are closely monitored for side effects and toxicities, with assessments for adverse events up to 90 days after the last dose. Tumor response is measured using imaging criteria RECIST v1.1, and participants undergo regular blood tests to check organ function and immune responses. The study includes safety evaluations during the first 28 days and after repeated doses. Participants remain in the study until disease progression or unacceptable side effects, with overall safety and clinical activity tracked throughout the trial period, which is expected to continue until December 2027.

A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies