Clinical Trials/NCT05125523

NCT05125523

Recruiting

Phase 1

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

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 site in 1 country264 target enrollmentDecember 28, 2021

ConditionsAdvanced Solid Tumors

InterventionsSirolimus for Injection (Albumin Bound)

DrugsSirolimus for Injection (Albumin Bound)

Overview

Phase: Phase 1
Intervention: Sirolimus for Injection (Albumin Bound)
Conditions: Advanced Solid Tumors
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Enrollment: 264
Locations: 1
Primary Endpoint: Number of participants with adverse events
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 28, 2021

End Date

November 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18-75 years (inclusive), no gender limitation.
•Patients must have a histologically or cytologically confirmed advanced or metastatic tumor for which no effective standard therapy is available, or have failed or been intolerant to standard therapies.
•At least one measurable lesion per RECIST version 1.
•Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to
•Life expectancy of ≥3 months.
•Suitable organs and hematopoietic function should be available. Laboratory tests during screening should meet the appropriate criteria.
•Signed informed consent form.

Exclusion Criteria

•Prior anticancer treatment or participation in another clinical study within 4 weeks (or 5 half-lives of the treated drug, whichever is longer) prior to the first dose of study drugs.
•Patients who have undergone major surgery within 4 weeks prior to starting study treatment, or who have not fully recovered from previous surgery.
•Unresolved toxicities from prior therapy greater than Grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) (except alopecia or any other toxicity without safety risks as judged by the investigator).
•History of serious cardiovascular disease.
•Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, and the investigator judges it to be unsuitable for inclusion.
•Known prior hypersensitivity to study drugs or any component in their formulations.
•Prior treatment with any mTOR inhibitor.
•Has received a live or live-attenuated virus vaccine within 30 days prior to consent.
•Uncontrollable active infection (CTCAE v5.0 ≥grade 2).
•Use of strong inhibitors and inducers of CYP3A4 within 2 weeks prior to receiving the first dose of study drug and still need to continue using this class of drug.

Arms & Interventions

Sirolimus for Injection (Albumin Bound)

Stage 1：Multiple doses of Sirolimus for Injection (Albumin Bound) will be administered intravenously. Stage 2：RP2D of Sirolimus for Injection (Albumin Bound) as determined during stage 1 will be administered intravenously.

Intervention: Sirolimus for Injection (Albumin Bound)

Outcomes

Primary Outcomes

Number of participants with adverse events

Time Frame: Up to 3 years

Overall response rate (Stage 2)

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

Secondary Outcomes

Disease Control Rate(Up to 3 years)
Peak concentration (Cmax)(Day 1 of cycle 1 to Day 1 of cycle 4 (85 days))
Elimination half-life (t1/2)(Day 1 of cycle 1 to Day 1 of cycle 4 (85 days))
Progression-free Survival(Up to 3 years)
4ebp-1 phosphorylation level in blood samples(Up to 168 hours post dose)
Clearance (CL)(Day 1 of cycle 1 to Day 1 of cycle 4 (85 days))
Area under the plasma concentration versus time curve (AUC)(Day 1 of cycle 1 to Day 1 of cycle 4 (85 days))
Peak time (Tmax)(Day 1 of cycle 1 to Day 1 of cycle 4 (85 days))
Distribution volume (Vz)(Day 1 of cycle 1 to Day 1 of cycle 4 (85 days))
Duration of Response(Up to 3 years)
S6K phosphorylation level in blood samples(Up to 168 hours post dose)
TSC1/2 status in tumor samples(Day 1 of cycle 1)
PTEN status in tumor samples(Day 1 of cycle 1)
PIK3CA status in tumor samples(Day 1 of cycle 1)