NCT07241936
Recruiting
Phase 1
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
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 site in 1 country444 target enrollmentStarted: November 13, 2025Last updated:
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Enrollment
- 444
- Locations
- 1
- Primary Endpoint
- The occurrence and frequency of adverse events (AE) and serious adverse events (SAE)
Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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.
Arms & Interventions
sirolimus (albumin-bound)+ DP303c
Experimental
Intervention: sirolimus (albumin-bound) (Drug)
sirolimus (albumin-bound)+ DP303c
Experimental
Intervention: DP303c (Drug)
sirolimus (albumin-bound)+ SYS6043
Experimental
Intervention: sirolimus (albumin-bound) (Drug)
sirolimus (albumin-bound)+ SYS6043
Experimental
Intervention: SYS6043 (Drug)
sirolimus (albumin-bound)+ SYS6002
Experimental
Intervention: sirolimus (albumin-bound) (Drug)
sirolimus (albumin-bound)+ SYS6002
Experimental
Intervention: SYS6002 (Drug)
sirolimus (albumin-bound)+ SYS6010
Experimental
Intervention: sirolimus (albumin-bound) (Drug)
sirolimus (albumin-bound)+ SYS6010
Experimental
Intervention: SYS6010 (Drug)
Outcomes
Primary Outcomes
The occurrence and frequency of adverse events (AE) and serious adverse events (SAE)
Time Frame: Up to approximately 36 weeks after the first participant is enrolled
dose - limiting toxicities (DLT)
Time Frame: Up to approximately 36 weeks after the first participant is enrolled
The recommended phase 2 dose
Time Frame: Up to approximately 36 weeks after the first participant is enrolled
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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