> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-sirolimus-for-injection-albumin-bound-in-patients-b5c7a65f-7343-4a12-aaaa-0ffb11c87e16 > Record changed: 2026-10-13 # A Study of Sirolimus for Injection (Albumin Bound) in Patients With Advanced Solid Tumors NCT05125523 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) Participants 264 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) Lead sponsor CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) Start date 2021-12-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Short title** A Study of Sirolimus for Injection (Albumin Bound) in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) ## Dates **Completion date** 2024-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **First posted** 2021-11-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Registry last updated** 2022-01-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Primary completion date** 2024-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Start date** 2021-12-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) ## Size and sites **Participants** 264 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Planned participants** 264 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Lead sponsor** CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) ## Identifiers **Registry ID** NCT05125523 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **ClinicalTrials.gov ID** NCT05125523 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) ## Outcomes ### Primary outcomes 1. Number of participants with adverse events Timeframe: Up to 3 years 2. Dose-Limiting Toxicities (Stage 1) Timeframe: Cycle 1 (Up to 28 days) 3. Maximum tolerated dose (Stage 1) Timeframe: Up to 1.5 years 4. Recommended phase 2 dose (Stage 1) Timeframe: Up to 1.5 years 5. Overall response rate (Stage 2) Timeframe: Up to 3 years ### Secondary outcomes 1. Area under the plasma concentration versus time curve (AUC) Timeframe: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days) 2. Peak concentration (Cmax) Timeframe: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days) 3. Peak time (Tmax) Timeframe: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days) 4. Distribution volume (Vz) Timeframe: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days) 5. Elimination half-life (t1/2) Timeframe: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days) 6. Clearance (CL) Timeframe: Day 1 of cycle 1 to Day 1 of cycle 4 (85 days) 7. Disease Control Rate Timeframe: Up to 3 years 8. Duration of Response Timeframe: Up to 3 years 9. Progression-free Survival Timeframe: Up to 3 years 10. 4ebp-1 phosphorylation level in blood samples Timeframe: Up to 168 hours post dose 11. S6K phosphorylation level in blood samples Timeframe: Up to 168 hours post dose 12. TSC1/2 status in tumor samples Timeframe: Day 1 of cycle 1 13. PTEN status in tumor samples Timeframe: Day 1 of cycle 1 14. PIK3CA status in tumor samples Timeframe: Day 1 of cycle 1 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. Age 18-75 years (inclusive), no gender limitation. 2. 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. 3. At least one measurable lesion per RECIST version 1.1. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2. 5. Life expectancy of ≥3 months. 6. Suitable organs and hematopoietic function should be available. Laboratory tests during screening should meet the appropriate criteria. 7. Signed informed consent form. ### Exclusion criteria 1. 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. 2. Patients who have undergone major surgery within 4 weeks prior to starting study treatment, or who have not fully recovered from previous surgery. 3. 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). 4. History of serious cardiovascular disease. 5. 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. 6. Known prior hypersensitivity to study drugs or any component in their formulations. 7. Prior treatment with any mTOR inhibitor. 8. Has received a live or live-attenuated virus vaccine within 30 days prior to consent. 9. Uncontrollable active infection (CTCAE v5.0 ≥grade 2). 10. 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. 11. History of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency, or organ transplant history. 12. HBsAg-positive with HBV viral load (VL) ≥1000 IU/mL; Hepatitis C Virus (HCV)-positive; Anti-treponema pallidum positive. 13. Women of child-bearing potential, or men whose partners are women of childbearing age, have not agree to use highly effective methods of contraception during dosing and for 6 months after study drug discontinuation; female patients has a positive serum pregnancy test within 7 days prior to receiving the first dose of study medication; lactating female. 14. Has history of other serious diseases judged by the investigator, which will threaten the safety of patients or interfere the study compliance, or other reasons are not suitable for participating in the study. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) ## Sites - Tianjin Medical University Cancer Institute and HospitalTianjin, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05125523) ## Related records ### Drugs (1) - [Sirolimus](https://trialight.com/data/asset/sirolimus-08da04e4-ea95-4587-95c4-83d583e56570.md) ### Lead sponsors (1) - [CSPC ZhongQi Pharmaceutical Technology Co., Ltd.](https://trialight.com/data/company/cspc-zhongqi-pharmaceutical-technology-co-ltd-3f55222d-62c5-4f61-b02b-614ae9c6300d.md) ### Targets (1) - [FKBP1A](https://trialight.com/data/target/fkbp1a-caa2dbe9-c679-5ba2-9bd0-18b303620352.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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