Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05508620
Status:
UNKNOWN
Last Update Posted:
2022-08-23
First Post:
2022-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Sirolimus for Injection (Albumin-bound) in Patients With Advanced Solid Tumors
Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: