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Clinical Trial Summary

The purpose of this study is to estimate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of Sirolimus for Injection (Albumin Bound) in patients with solid malignancies.


Clinical Trial Description

This study will be conducted in two stages. Stage 1: To evaluate the safety and tolerability of Sirolimus for Injection (Albumin Bound) in patients with advanced tumors, determine the MTD and RP2D. The dose escalation scheme using the accelerated titration design for dose 1 and the rolling-six design for the remaining doses. Stage 2: To preliminarily assess the antitumor activity of Sirolimus for Injection (Albumin Bound). Patients will be assigned to different cohorts based on their tumor type. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05125523
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact Xuekun Yao
Phone 0311-67808678
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date November 2021
Completion date November 2024

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