Phase 12 Open-Label Study of Oral PRJ1-3024 for Safety and Effectiveness in Advanced Solid Tumors

What this Trial Is About

Researchers are studying PRJ1-3024, an oral drug, in people with advanced solid tumors that have returned or do not respond to standard treatments. This open-label Phase 12 trial aims to assess the safety, tolerability, how the body processes the drug, and its preliminary effects on tumors. The study will also determine the highest dose that patients can tolerate and recommend doses for further research. The study has two parts a dose escalation phase and an extension phase. In the first phase, small groups of participants receive increasing doses of PRJ1-3024 taken once daily starting at 80 mg to identify the maximum tolerated dose. Afterward, the extension phase uses the recommended dose from the first part to evaluate longer-term safety and preliminary effectiveness. Treatment can continue for up to two years if patients benefit and do not show clear disease progression. Participants will take PRJ1-3024 orally daily and be monitored closely for side effects and tumor response. Researchers will track dose-limiting toxicities during the first 21 days and observe adverse events, drug levels in the body, tumor shrinkage, and response duration over up to 24 months. The study includes regular assessments and requires participants to record their medication adherence. The total participation duration varies based on individual response and tolerability.

A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors