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Spots Global Cancer Trial Database for A Study of Sirolimus for Injection (Albumin-bound) in Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: A Study of Sirolimus for Injection (Albumin-bound) in Patients With Advanced Solid Tumors

Official Title: A Phase Ib Study to Evaluate the Safety and Efficacy of Sirolimus for Injection (Albumin-bound) in Patients With Malignant Solid Tumors With TSC1/2 Genetic Alterations

Study ID: NCT05508620

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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