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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
264
Sirolimus for Injection (Albumin Bound), intravenously, once a week, 28 days per cycle (three weeks-on and one week-off)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGNumber of participants with adverse events
Time frame: Up to 3 years
Dose-Limiting Toxicities (Stage 1)
Time frame: Cycle 1 (Up to 28 days)
Maximum tolerated dose (Stage 1)
Time frame: Up to 1.5 years
Recommended phase 2 dose (Stage 1)
Time frame: Up to 1.5 years
Overall response rate (Stage 2)
Time frame: Up to 3 years
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Peak concentration (Cmax)
Time frame: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Peak time (Tmax)
Time frame: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Distribution volume (Vz)
Time frame: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Elimination half-life (t1/2)
Time frame: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Clearance (CL)
Time frame: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days)
Disease Control Rate
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 3 years
Duration of Response
Time frame: Up to 3 years
Progression-free Survival
Time frame: Up to 3 years
4ebp-1 phosphorylation level in blood samples
Time frame: Up to 168 hours post dose
S6K phosphorylation level in blood samples
Time frame: Up to 168 hours post dose
TSC1/2 status in tumor samples
Time frame: Day 1 of cycle 1
PTEN status in tumor samples
Time frame: Day 1 of cycle 1
PIK3CA status in tumor samples
Time frame: Day 1 of cycle 1