NCT06209385

A Phase 1 Study of YZJ-5053 Tablets in Participants With Advanced Solid Tumors

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of YZJ-5053 Tablets in Participants With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 157 (estimated)
• Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of YZJ-5053 Tablets in Participants with Advanced Solid Tumors

Detailed description

Part1(phase 1a) :To define the maximum tolerated dose (MTD) and/or a recommended phase 2 dose(RP2D). To evaluate the safety and tolerability of YZJ-5053 tables in participants with advanced solid tumors. Part2(phase 1b) : To define the RP2D. To evaluate the safety and tolerability of YZJ-5053 tables in subjects with advanced solid tumors

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	YZJ-5053 tablets	YZJ-5053 tablets will be administrated orally QD for 21 days

Timeline

• Start date: 2023-08-11
• Primary completion: 2027-10-01
• Completion: 2028-01-01
• First posted: 2024-01-17
• Last updated: 2024-01-17

Locations

4 sites across 1 country: China