NCT05291182

A Phase I Study of SY-4835 in Patients With Advanced Solid Tumors

A First-in-human, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of SY-4835 Tablets in Patients With Advanced Solid Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shouyao Holdings (Beijing) Co. LTD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, open-label, single-arm, first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of SY-4835 administered orally in patients with advanced solid tumors.

Detailed description

This study is a first-in-human phase I study of SY-4835, a potent WEE1 inhibitor, in patients with advanced solid tumor. Dose-escalation study is conducted to evaluate primary endpoints and secondary endpoints including the maximum tolerated dose (MTD), Dose-limiting toxicity (DLT), pharmacokinetics (PK) parameters and recommended phase II dose (RP2D), and the safety, tolerability and pharmacokinetics (PK) profiles of SY-4835 are characterized in this study.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	SY-4835	WEE1 inhibitor

Timeline

• Start date: 2021-06-28
• Primary completion: 2024-06-28
• Completion: 2024-12-28
• First posted: 2022-03-22
• Last updated: 2024-02-02

Locations

1 site across 1 country: China