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Recruiting NCT07241936

A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors

Phase I / Phase II Interventional Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sirolimus (albumin-bound), DP303c, SYS6043, SYS6002.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug sirolimus (albumin-bound)
    intravenous infusion
  • Drug DP303c
    intravenous infusion
  • Drug SYS6043
    intravenous infusion
  • Drug SYS6002
    intravenous infusion
  • Drug SYS6010
    intravenous infusion

Primary outcome measures

  • The occurrence and frequency of adverse events (AE) and serious adverse events (SAE) [Time frame: Up to approximately 36 weeks after the first participant is enrolled]
  • dose - limiting toxicities (DLT) [Time frame: Up to approximately 36 weeks after the first participant is enrolled]
  • The recommended phase 2 dose [Time frame: Up to approximately 36 weeks after the first participant is enrolled]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07241936 · HB1901-012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗