Albumin-bound sirolimus combined with different antibody-drug conjugates for 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

This trial will try giving albumin-bound sirolimus together with various antibody-drug conjugates to people with advanced solid tumors to see if the combinations are safe and show anticancer activity.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 444 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07241936 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 with histologically confirmed unresectable or metastatic solid tumors, at least one measurable lesion, ECOG performance status 0–1, adequate organ function, and willingness to provide tumor samples are the intended participants.

Not a fit: Patients previously treated with similar antibody-conjugated drugs, those with uncontrolled CNS metastases or active leptomeningeal disease, or those with severe uncontrolled cardiovascular/cerebrovascular disease are unlikely to benefit.

Why it matters

Potential benefit: If successful, this combination could provide a new treatment option that controls disease in some patients with advanced solid tumors.

How similar studies have performed: While antibody-drug conjugates and mTOR-pathway agents have each shown activity in some cancers, combining albumin-bound sirolimus with these specific ADCs is largely novel and not yet proven.

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.

Where this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Clinical Trials Information Group officer

Conditions Advanced Solid Tumors