Advanced Solid Tumors
Conditions
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).
Interventions
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose escalation and expansion
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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 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.
Design outcomes
Primary
| 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 |
Countries
China
Contacts
Primary ContactClinical Trials Information Group officer
Outcome results
None listed