Spots Global Cancer Trial Database for A Phase I Study of SY-4835 in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: A Phase I Study of SY-4835 in Patients With Advanced Solid Tumors
Official Title: 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
Study ID: NCT05291182
Conditions
Interventions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China
Contact Details
Name: Yinghui Sun, PhD
Affiliation: Shouyao Holdings (Beijing) Co. LTD
Role: STUDY_DIRECTOR
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