Trials / Unknown
UnknownNCT05508620
A Study of Sirolimus for Injection (Albumin-bound) in Patients With Advanced Solid Tumors
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sirolimus for Injection (Albumin-bound) | Intravenous infusion |
Timeline
- Start date
- 2022-10-01
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2022-08-19
- Last updated
- 2022-08-23
Source: ClinicalTrials.gov record NCT05508620. Inclusion in this directory is not an endorsement.