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

Официальное название

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

Обзор

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).

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07241936 · HB1901-012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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