A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: Advanced Solid Tumors
In brief
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).
Key facts
- Study ID
- NCT07241936
- Run by
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- People needed
- 444
- Starts
- 2025-11-13
- Expected to finish
- 2028-10-30
- Last updated by the study team
- 2025-11-28
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Fudan University Shanghai Cancer Center — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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