Phase I Trial Evaluating Safety and Dose of PA5 Intravenous Treatment for Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating PA5, a biological drug given by intravenous infusion, to understand its safety, tolerability, and how the body processes it in adults with advanced solid tumors that have failed or cannot benefit from standard treatments. This Phase I clinical trial aims to find the maximum tolerated dose and the recommended dose for future studies. The study includes two parts dose escalation to find safe dose levels, and dose expansion to further evaluate safety and effects. In the dose escalation phase, participants receive PA5 once intravenously on Day 1 of a 28-day cycle. If no serious side effects occur, dosing continues from Cycle 2 with adjusted frequencies every 2 to 4 weeks at increasing dose levels of 0.1 to 1.2 mgkg. In the expansion phase, participants receive PA5 infusions at a frequency based on escalation phase results. Treatment continues until disease progression, unacceptable toxicity, a decision by the investigator, or participant withdrawal. Participants will be monitored regularly with assessments to track side effects, dose-limiting toxicities, and the maximum tolerated dose. Safety evaluations and dose recommendations are made after each cycle. The main outcomes measured include adverse events and dose tolerability up to 7 cycles or until treatment ends. The trial lasts until the end of treatment or withdrawal, supporting further research into PA5 for advanced solid tumors.

A Clinical Study of PA5 in Patients With Advanced Solid Tumors