NCT06950086

Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors

A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of the CDK2/4/6 Inhibitor TYK-00540 Tablets in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: TYK Medicines, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety, pharmacokinetics, and preliminary antitumor activity of TYK-00540 as monotherapy or combined with fulvestrant in advanced solid tumors.

Detailed description

This is an open-label, multi-center, dose-escalation and expansion phase I/II study to evaluate dose limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) in subjects with locally advanced or metastatic solid tumors. To investigate the pharmacokinetic profile of TYK-00540 and its metabolites after single then multiple doses of TYK-00540 administered orally once daily. To assess preliminary effectiveness. To evaluate the efficacy of TYK-00540 combined with fulvestrant in subjects with ER+/HER2- breast cancer who have relapsed or progressed after treatment with CDK4/6 inhibitors

Conditions

• HR-positive, HER2-negative Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	TYK-00540	Increased dose cohorts from low to MTD (5mg Cohort 1;10 mg Cohort 2; 20 mg Cohort 3; 30 mg Cohort 4;40 mg Cohort 5) decreased dose cohorts for the combination (TYK-00540 30 mg+Fulvestrant Cohort 1;TYK-00540 20mg +Fulvestrant)

Timeline

• Start date: 2024-01-02
• Primary completion: 2026-09-01
• Completion: 2026-11-01
• First posted: 2025-04-29
• Last updated: 2025-04-29

Locations

2 sites across 1 country: China