Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT05508620
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.
Study:
NCT05508620
Study Brief:
Protocol Section:
NCT05508620