Advanced Solid Tumors Clinical Trial
Official title:
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
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.
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. ;
Status | Clinical Trial | Phase | |
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Active, not recruiting |
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