NCT05125523

A Study of Sirolimus for Injection (Albumin Bound) in Patients With Advanced Solid Tumors

A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Antitumor Activity of Sirolimus for Injection (Albumin Bound) in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of Sirolimus for Injection (Albumin Bound) in patients with solid malignancies.

Detailed description

This study will be conducted in two stages. Stage 1: To evaluate the safety and tolerability of Sirolimus for Injection (Albumin Bound) in patients with advanced tumors, determine the MTD and RP2D. The dose escalation scheme using the accelerated titration design for dose 1 and the rolling-six design for the remaining doses. Stage 2: To preliminarily assess the antitumor activity of Sirolimus for Injection (Albumin Bound). Patients will be assigned to different cohorts based on their tumor type.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Sirolimus for Injection (Albumin Bound)	Sirolimus for Injection (Albumin Bound), intravenously, once a week, 28 days per cycle (three weeks-on and one week-off)

Timeline

• Start date: 2021-12-28
• Primary completion: 2024-06-01
• Completion: 2024-11-01
• First posted: 2021-11-18
• Last updated: 2022-01-25

Locations

1 site across 1 country: China