Albumin-bound sirolimus combined with different antibody-drug conjugates for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, non-randomized Phase 1/2 trial enrolls adults with unresectable or metastatic solid tumors to receive albumin-bound sirolimus combined with one of several antibody-drug conjugates (DP303c, SYS6043, SYS6002, SYS6010). Phase 1 uses dose-escalation cohorts to define safety, tolerability, dose-limiting toxicities, and pharmacokinetics and to identify recommended phase 2 dose(s). Phase 2 utilizes PK-expansion cohorts to collect preliminary efficacy data, including objective tumor responses by RECIST 1.1. Eligible participants must have measurable disease, ECOG 0–1, adequate organ and marrow function, and be willing to provide tumor tissue.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Clinical Trials Information Group officer
• Email: ctr-contact@cspc.cn
• Phone: 86-0311-69085587

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.