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

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).

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: sirolimus (albumin-bound); Drug: DP303c; Drug: SYS6043; Drug: SYS6002; Drug: SYS6010

• Study Type: Interventional
• Enrollment (Estimated): 444
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group officer; Phone Number: 86-0311-69085587; Email: ctr-contact@cspc.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Jian Zhang; Email: syner2000@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sirolimus (albumin-bound)+ DP303c	Drug: sirolimus (albumin-bound); intravenous infusion; Drug: DP303c; intravenous infusion
Experimental: sirolimus (albumin-bound)+ SYS6043	Drug: sirolimus (albumin-bound); intravenous infusion; Drug: SYS6043; intravenous infusion
Experimental: sirolimus (albumin-bound)+ SYS6002	Drug: sirolimus (albumin-bound); intravenous infusion; Drug: SYS6002; intravenous infusion
Experimental: sirolimus (albumin-bound)+ SYS6010	Drug: sirolimus (albumin-bound); intravenous infusion; Drug: SYS6010; intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The occurrence and frequency of adverse events (AE) and serious adverse events (SAE)	Up to approximately 36 weeks after the first participant is enrolled
dose - limiting toxicities (DLT)	Up to approximately 36 weeks after the first participant is enrolled
The recommended phase 2 dose	Up to approximately 36 weeks after the first participant is enrolled

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Estimated): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Macrolides; Lactones; Sirolimus
• Other Study ID Numbers: HB1901-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No