RecruitingPhase 1Phase 2NCT07241936

A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors

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

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Enrollment

444 participants

Start Date

Nov 13, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

\. Subjects aged 18 to 75 years (inclusive).
\. Patients with advanced solid tumors that are unresectable or metastatic and confirmed by histology or cytology.
\. At least one measurable lesion, as defined by RECIST 1.1 criteria.
\. ECOG performance status of 0 or 1.
\. Expected survival ≥ 3 months.
\. Adequate function of major organs and bone marrow.
\. Willing to provide samples of previously removed tumors or undergo fresh tumor biopsy.
\. Women or man of childbearing potential must use highly effective contraception.
\. Able to understand and voluntarily sign the written informed consent form (ICF).

Exclusion Criteria12

\. Previous use of antibody-conjugated drugs with similar loading agents for treatment.
\. Previous anti-tumor treatment drugs were not adequately removed.
\. Active leptomeningeal disease or uncontrolled CNS metastasis.
\. Having a history of severe or uncontrolled cardiovascular or cerebrovascular diseases.
\. 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.
\. 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.
\. 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.
\. Currently suffering from skin diseases that require oral or intravenous medication treatment.
\. Had a history of ulcerative colitis or Crohn's disease.
\. 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.
\. Known to be allergic to any component of the test drug, or allergic to the humanized monoclonal antibody product.
\. Participants with poor compliance.