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NCT Number: NCT07241936

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

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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, China

Location status: Recruiting

Location contact

Jian Zhang

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sirolimus (albumin-bound)

Drug

intravenous infusion

DP303c

Drug

intravenous infusion

SYS6043

Drug

intravenous infusion

SYS6002

Drug

intravenous infusion

SYS6010

Drug

intravenous infusion

Primary outcomes

  1. 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

  2. dose - limiting toxicities (DLT)

    Time frame: Up to approximately 36 weeks after the first participant is enrolled

  3. The recommended phase 2 dose

    Time frame: Up to approximately 36 weeks after the first participant is enrolled

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Information Group officer

CONTACT

[email protected]

86-0311-69085587

Sponsors and collaborators

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 21, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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