Phase I Study of TQB3107 Tablets to Evaluate Safety and Dosage in Adults With Advanced Malignant Tumors

What this Trial Is About

Researchers are evaluating TQB3107, a targeted inhibitor designed to induce cell death and stop tumor growth, in patients with advanced cancers. This Phase I clinical trial aims to assess the safety and tolerability of TQB3107 tablets, determine dose-limiting toxicities, find the maximum tolerated dose, and recommend a dose for future Phase II studies. Participants receive TQB3107 tablets following one of two dosing schedules either daily for five consecutive days each week with a two-day break per 28-day cycle, or intermittent dosing every 28 days. The study begins with an initial single fasting dose followed by a seven-day observation before continuing the dosing cycles. This design allows researchers to monitor participants closely during the first cycle to assess safety and dosing effects. During the study, participants will have regular assessments including pharmacokinetic blood sampling at multiple time points to measure drug levels, and evaluations of dose-limiting toxicities and maximum tolerated dose at the end of the first 28-day cycle. Longer-term outcomes such as response rates, disease control, progression-free survival, and overall survival will be followed for up to three years. Participants are monitored for up to 24 months for recommended dosing and safety, with comprehensive evaluations throughout the study period.

A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors