NCT07241936 A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors
| NCT ID | NCT07241936 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 444 participants |
| Start Date | 2025-11-13 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 444 participants in total. It began in 2025-11-13 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07241936 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07241936 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07241936 currently recruiting?
Yes, NCT07241936 is actively recruiting participants. Contact the research team at ctr-contact@cspc.cn for enrollment information.
Where is the NCT07241936 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07241936 clinical trial?
NCT07241936 is sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. The trial plans to enroll 444 participants.