Actively Recruiting
Phase 1 Study of Oral TYK-00540 in Adults with Advanced or Metastatic Solid Tumors to Find Safe Dose and Assess Effects
Led by TYK Medicines, Inc · Updated on 2024-02-07
156
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying TYK-00540 in adult patients with locally advanced or metastatic solid tumors to assess its safety and tolerability. The trial aims to identify dose-limiting toxicities and determine the maximum tolerated dose. Additionally, the study investigates how the drug and its metabolites behave in the body after single and multiple oral doses, while also assessing early signs of effectiveness. The study has two main parts a dose-escalation stage and a dose-expansion stage. During the escalation phase, participants receive multiple oral doses of TYK-00540 tablets twice daily every 28 days to find the maximum tolerated dose. In the expansion phase, an optimal dose identified from the first stage is given twice daily in 28-day cycles to further evaluate safety and effects. Participants will undergo regular assessments including monitoring for dose-limiting toxicities within the first 31 days, tracking adverse events throughout treatment and for 28 days after, and measuring tumor response over at least 24 weeks. Blood samples will be collected at various times to study drug levels in the body. Safety will be closely monitored, and the study is expected to continue until December 2026.
CONDITIONS
Brief Title
A Study of TYK-00540 in Adult Patients With Solid Tumors
Research Team
J
Jian Zhang, MD
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