Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DP303c | Drug | — | UNRESOLVED |
| sirolimus (albumin-bound) | Drug | Sirolimus | ALIAS |
| SYS6002 | Drug | — | UNRESOLVED |
| SYS6010 | Drug | — | UNRESOLVED |
| SYS6043 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- sirolimus (albumin-bound)+ DP303c
- interventionNames
- Drug: sirolimus (albumin-bound)
- Drug: DP303c
- type
- EXPERIMENTAL
- label
- sirolimus (albumin-bound)+ SYS6043
- interventionNames
- Drug: sirolimus (albumin-bound)
- Drug: SYS6043
- type
- EXPERIMENTAL
- label
- sirolimus (albumin-bound)+ SYS6002
- interventionNames
- Drug: sirolimus (albumin-bound)
- Drug: SYS6002
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available