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Clinical Trial Summary

This is an open-label, multi-center phase 1b study to evaluate the safety and efficacy of Sirolimus for injection (albumin-bound) in patients with malignant solid tumors with TSC1 or TSC2 genetic alterations.


Clinical Trial Description

This study will be conducted in two stages. Stage 1: To evaluate the safety, tolerability and pharmacokinetics of Sirolimus for injection (albumin-bound), and determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). The Rolling-six design will be used for dose escalation. Stage 2: To assess the antitumor activities of Sirolimus for injection (albumin-bound) in patients with malignant solid tumors harboring genetic alterations in TSC1 or TSC2. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05508620
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact Zhehao Piao
Phone +86-024-81916392
Email pzpy@163.com
Status Not yet recruiting
Phase Phase 1
Start date October 2022
Completion date December 2024

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