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

Renal Cell Cancer Metastatic Clinical Trial

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

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03876925
Study type Interventional
Source Sunshine Lake Pharma Co., Ltd.
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date June 25, 2018
Completion date May 12, 2020
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