Study of XZP-5955 Tablets for Adults With NTRK or ROS1 Fusion Positive Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of XZP-5955 tablets in patients who have advanced solid tumors with specific gene fusions called NTRK or ROS1. This study is a combined phase III trial that focuses on patients with locally advanced or metastatic solid tumors where these gene fusions are present. The trial is conducted by Xuanzhu Biopharmaceutical Co., Ltd. and aims to better understand how this drug behaves in the body and its potential impact on tumor response. Participants will receive XZP-5955 tablets orally. In phase I dose escalation, the drug is given as a single dose on day 1 and then daily from day 4 in 21-day cycles. During phase I dose expansion and phase II, patients take the tablets once daily continuously in 21-day cycles. Some patients will have additional blood samples taken to study how the drug is processed in the body. The study does not use a comparison group or placebo. Throughout the trial, participants will undergo regular assessments including scans to measure tumor size, blood tests to monitor drug levels and organ function, and evaluations for side effects. The main outcomes measured include the highest safe dose, frequency of adverse events, and the overall response rate of tumors over 2 to 3 years after starting treatment. Long-term follow-up will also look at progression-free survival, duration of response, and overall survival. Safety and drug effects will be closely monitored during and after treatment.

A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors