Phase 1 Study of HJ-004-02 Tablets for Treating Non-squamous Non-small Cell Lung Cancer with EGFR Mutations

What this Trial Is About

Researchers are evaluating the safety, tolerability, how the body processes, and early anti-tumor effects of HJ-004-02 tablets in patients with non-squamous non-small cell lung cancer NSCLC who have specific mutations in the epidermal growth factor receptor EGFR. This Phase 1 clinical trial is designed to study patients who have progressed after standard treatments or are unable to receive them, aiming to better understand this new drugs potential in this advanced cancer type. The treatment involves taking HJ-004-02 tablets by mouth while fasting, using warm water. The study includes both single-dose and multiple-dose phases, with multiple doses taken once daily for 28-day cycles. The dosing frequency may be adjusted based on study findings. Participants will be monitored throughout these cycles to assess how the drug is tolerated and processed by the body. Participants will undergo regular evaluations including tumor assessments using standard criteria, blood tests to monitor blood cell counts and organ function, and safety checks for any adverse effects or dose-limiting toxicities. The study will monitor adverse events for about one year. Researchers will also collect archived tumor tissue samples to confirm eligibility. The total participation duration varies with the treatment cycles and follow-up assessments.

A Phase l Clinical Study to Evalute the Safety,Tolerability,Pharmacokinetic Characteristics,and Preliminary Anti-tumor Efficacy of HJ-004-02 Tablets in Patients With Non-squamous Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutations