Phase I Study of TQB3019 Capsules to Assess Safety, Tolerability, Pharmacokinetics, and Early Effects in Adults with Advanced Malignant Tumors

What this Trial Is About

Researchers are studying the safety, tolerability, pharmacokinetics, and early effects of TQB3019 capsules in people with advanced malignant tumors. This Phase I clinical trial uses a single-center, open, non-randomized, single-arm design. The study includes two phases dose escalation and dose expansion, aiming to find appropriate dosing and assess initial responses in patients with recurrent or refractory blood cancers who have at least one measurable tumor. Participants take TQB3019 capsules orally once daily on an empty stomach, with doses ranging from 50 to 600 mg per day. Each treatment cycle lasts 28 days. The study includes both single-dose and continuous dosing regimens, with assessments made throughout these cycles to understand the drugs behavior and effects. During the trial, participants undergo regular monitoring for side effects, laboratory tests, and evaluations of tumor response. Researchers measure dose limiting toxicity, maximum tolerated dose, and recommended doses for future studies, along with overall response rates and survival outcomes up to about three years. Pharmacokinetic parameters such as drug concentration over time are monitored closely at multiple time points within each 28-day cycle to understand how the drug is processed by the body.

A Clinical Trial on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3019 Capsule in Subjects With Advanced Malignant Tumors