NCT03876925

A Single Arm, Open-label,Phase Ib Study of CT053PTSA in Preciously Treated Patients With Advanced and Metastatic RCC

A Single Arm, Open-label,Phase Ib Study of CT053PTSA in Preciously Treated Patients With Advanced and Metastatic Renal Cell Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ib,single arm,open label study evaluating the safety and efficacy of CT053PTSA in patients with advanced and metastatic renal cell cancer who have progressed from previous treatment

Detailed description

This study is being carried out in two parts,part 1 and part 2. Part 1: This is the dose-escalation part. The primary purpose of the part 1 portion is to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD), and recommend the appropriate doses of CT053PTSA for further study Part 2: This is the expansion part.The part 2 portion of this study will continue to evaluate the safety and efficacy of CT053PTSA at the appropriate dose recommended in Part 1,in patients with advanced and metastatic RCC

Conditions

• Renal Cell Cancer Metastatic

Interventions

Type	Name	Description
DRUG	CT053PTSA	Patients will received oral CT053PTSA once daily until disease progression or intolerable toxicity or subject's withdrawal from treatment ,each cycle is defined as 28 days

Timeline

• Start date: 2018-06-25
• Primary completion: 2020-03-01
• Completion: 2020-05-12
• First posted: 2019-03-15
• Last updated: 2021-03-24

Locations

1 site across 1 country: China