Phase I Study of AK138D1 to Evaluate Safety and Effectiveness in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor effects of AK138D1 in adults with advanced solid tumors. This first-in-human, open-label Phase I trial includes patients whose tumors are resistant or intolerant to standard treatments, aiming to better understand this new drugs potential. The study includes two parts dose escalation to find the maximum tolerated dose and dose expansion to determine the recommended dose for further research. Participants will receive AK138D1 through intravenous infusions at pre-determined dose levels based on their study group. The first part focuses on gradually increasing doses to identify safe limits, while the second part treats more patients with the recommended dose to further assess safety and early effectiveness. This process helps define appropriate dosing for future studies. During the trial, participants will undergo regular monitoring for side effects and dose-related toxicities for up to two years. Researchers will perform scans and measurements to track tumor response using standard criteria and collect blood samples to study drug levels, immune reactions, and survival outcomes. The study also tracks how long participants respond to treatment and how long they live without disease progression, providing a comprehensive view of safety and preliminary benefits over time.

A Phase I Study of AK138D1 in the Treatment of Advanced Solid Tumors