Actively Recruiting
A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors
Led by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Updated on 2025-11-28
444
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years (inclusive)
- Diagnosis of advanced, unresectable, or metastatic solid tumors confirmed by histology or cytology
- At least one measurable tumor lesion as defined by RECIST 1.1
- ECOG performance status of 0 or 1
- Expected survival of 3 months or longer
- Adequate function of major organs and bone marrow
- Willingness to provide samples of previously removed tumors or undergo fresh tumor biopsy
- Use of highly effective contraception if of childbearing potential
- Ability to understand and voluntarily sign the informed consent form
You will not qualify if you...
- Previous treatment with antibody-conjugated drugs with similar loading agents
- Incomplete removal of previous anti-tumor treatment drugs
- Active leptomeningeal disease or uncontrolled brain metastasis
- History of severe or uncontrolled cardiovascular or cerebrovascular diseases
- Previous or current interstitial lung disease requiring glucocorticoid treatment or non-infectious pneumonia
- Severe lung diseases affecting lung function within 6 months before treatment or need for supplemental oxygen
- Current eye diseases requiring intervention or history of serious corneal-related eye diseases or unwillingness to stop wearing contact lenses during the study
- Skin diseases requiring oral or intravenous medication
- History of ulcerative colitis or Crohn's disease
- Need for systemic antibacterial, antifungal, or antiviral treatment for severe chronic or active infections within 14 days before treatment, and active tuberculosis not cured
- Known allergy to components of the test drug or humanized monoclonal antibody products
- Poor compliance with study requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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