> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-sirolimus-albumin-bound-in-combination-with-191aa573-7e93-4d1d-9e6c-ea088bb8e0c2 > Record changed: 2026-10-13 # A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors NCT07241936 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) Participants 444 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) Lead sponsor CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) Start date 2025-11-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) ## Title and summary **Summary** This study adopts a multi-center, open-label, non-randomized trial design. It plans to enroll patients with Advanced solid tumor. Dose-escalation and PK-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with Different ADCs (DP303c/SYS6043/SYS6002/SYS6010) in this patient population, and to confirm the recommended phase 2 dose (RP2D). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Short title** A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Official title** A Phase Ib/II Clinical Trial on the Safety and Efficacy of Sirolimus (Albumin-bound) Combined With Different ADCs in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) ## Dates **Completion date** 2028-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **First posted** 2025-11-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Registry last updated** 2025-11-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Primary completion date** 2027-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Start date** 2025-11-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) ## Size and sites **Participants** 444 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Planned participants** 444 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Lead sponsor** CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) ## Identifiers **Registry ID** NCT07241936 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **ClinicalTrials.gov ID** NCT07241936 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) ## Outcomes ### Primary outcomes 1. The occurrence and frequency of adverse events (AE) and serious adverse events (SAE) Timeframe: Up to approximately 36 weeks after the first participant is enrolled 2. dose - limiting toxicities (DLT) Timeframe: Up to approximately 36 weeks after the first participant is enrolled 3. The recommended phase 2 dose Timeframe: Up to approximately 36 weeks after the first participant is enrolled Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - 1\. Subjects aged 18 to 75 years (inclusive). - 2\. Patients with advanced solid tumors that are unresectable or metastatic and confirmed by histology or cytology. - 3\. At least one measurable lesion, as defined by RECIST 1.1 criteria. - 4\. ECOG performance status of 0 or 1. - 5\. Expected survival ≥ 3 months. - 6\. Adequate function of major organs and bone marrow. - 7\. Willing to provide samples of previously removed tumors or undergo fresh tumor biopsy. - 8\. Women or man of childbearing potential must use highly effective contraception. - 9\. Able to understand and voluntarily sign the written informed consent form (ICF). ### Exclusion criteria - 1\. Previous use of antibody-conjugated drugs with similar loading agents for treatment. - 2\. Previous anti-tumor treatment drugs were not adequately removed. - 3\. Active leptomeningeal disease or uncontrolled CNS metastasis. - 4\. Having a history of severe or uncontrolled cardiovascular or cerebrovascular diseases. - 5\. Previous interstitial lung disease requiring glucocorticoid treatment, Or currently suffering from interstitial lung disease/non-infectious pneumonia, or the imaging examination during the screening period cannot rule out interstitial pneumonia/lung disease. - 6\. Patients who developed severe and moderately severe lung diseases that significantly affected lung function within 6 months of the first medication administration; patients requiring supplementary oxygen therapy. - 7\. Individuals who currently have eye diseases such as corneal disorders, retinal disorders, or active ocular infections that require intervention, or who have a history of serious corneal-related eye diseases in the past; or who are unwilling to stop wearing corneal contact lenses during the study; or who have other existing eye diseases that affect the assessment of ocular toxicity after the administration of the investigational drug. - 8\. Currently suffering from skin diseases that require oral or intravenous medication treatment. - 9\. Had a history of ulcerative colitis or Crohn's disease. - 10\. Within 14 days prior to the first administration of the medication, there is a need for systemic antibacterial, antifungal or antiviral treatment for severe chronic or active infections, and there is no cure for active tuberculosis. - 11\. Known to be allergic to any component of the test drug, or allergic to the humanized monoclonal antibody product. - 12\. Participants with poor compliance. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) ## Sites - Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07241936) ## Related records ### Drugs (2) - [Sirolimus](https://trialight.com/data/asset/sirolimus-08da04e4-ea95-4587-95c4-83d583e56570.md) - [Trastuzumab envedotin](https://trialight.com/data/asset/trastuzumab-envedotin-83d8cfd5-016d-491f-8e0d-87666f69f461.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. 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