Phase I Study Evaluating Safety, Tolerability, and Preliminary Anti-Tumor Effects of SWA1211 Tablets in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of SWA1211 tablets in people with advanced solid tumors. This Phase I, first-in-human, open-label study aims to find the maximum tolerated or recommended dose of SWA1211 and understand its side effects and how the body processes the drug. The study is sponsored by Beijing StoneWise Technology Co., Ltd and includes both dose escalation and dose expansion phases. The study uses an accelerated titration combined with a traditional 33 dose escalation design in Phase 1a, with six planned dose-escalation groups. After completing dose escalation, the trial moves to Phase 1b, a dose expansion study with 1 to 2 groups of 20 to 30 participants each. SWA1211 is given orally as tablets daily. The study does not use blinding and participants are randomly assigned. Participants will be monitored for adverse events and serious adverse events from the first dose until 90 days after the last dose or start of new cancer treatment, up to about 12 months. Researchers will assess safety, collect blood samples to study drug levels, and evaluate anti-tumor effects. The study requires participants to have certain health and organ function criteria and includes tumor tissue sample collection during screening if possible. Participants may be involved in regular assessments throughout the study duration.

A Phase I First-in-Human Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of SWA1211 Tablets in Subjects With Advanced Solid Tumors