A Phase Ib Study of HS-10504 Combined Therapy in NSCLC

Официальное название

A Phase Ib Study of the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of HS-10504 Combined Therapy in Advanced Non-small Cell Lung Cancer Patients

Обзор

This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-10504 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Вмешательства

• Препарат HS-10504
  HS-10504 administered orally every day
• Препарат SHR-A2009
  SHR-A2009 administered intravenously
• Препарат HS-20122
  HS-20122 administered intravenously
• Препарат HS-20117
  HS-20117 administered intravenously
• Препарат SHR-1826
  SHR-1826 administered intravenously
• Препарат SHR-A2102
  SHR-A2102 administered intravenously

Первичные конечные точки

• RP2D for Combination [Срок оценки: Through the full duration of this trial, approximately 2 years]
• ORR [Срок оценки: Through the full duration of this trial, approximately 2 years]
• TEAE [Срок оценки: Through the full duration of this trial, approximately 2 years]
• TRAE [Срок оценки: Through the full duration of this trial, approximately 2 years]
• SAE [Срок оценки: Through the full duration of this trial, approximately 2 years]

Критерии участия

Критерии включения

• Cohort1:participants with EGFR mutation advanced stage NSCLC，disease progression on or after prior treatment；
• Cohort2:participants with MET position advanced stage NSCLC，disease progression on or after prior treatment；
• With at least 1 target lesion according to RECIST 1.1.
• Appropriate organ function
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 and no deterioration within 2 weeks prior to the first dose.
• Minimum expected survival longer than 12 weeks
• Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent form (ICF) through 6 months after the last dose; male subjects are willing to use barrier contraception (i.e., condom) from signing the ICF through 6 months after the last dose.
• Voluntarily participate in this clinical trial, understand the study procedures, and be able to sign written informed consent form.

Критерии исключения

• Insufficient wash out duration of prior systemic anticancer therapy
• Local radiotherapy within 2 weeks prior to first dose of investigational drug
• Pleural/abdominal effusion requires clinical intervention
• Major surgery within 4 weeks prior to first dose of investigational drug
• History of drugs may prolong QT interval
• Have any grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior anti-tumor therapy (except alopecia and residual neurotoxicity).
• Presence of brain metastasis or carcinomatous meningtitis
• History of other primary malignancies
• Significant, uncontrolled, or active cardiovascular diseases
• Severe or poorly controlled diabetes
• Extremely obesity or emaciation
• Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose
• Severe arteriovenous thrombotic events (e.g., deep venous thrombosis, pulmonary embolism) within 3 months prior to the first dose
• Severe infection within 4 weeks
• History of systemic glucocorticoids over 28 days prior to first dose of investigational drug
• Presence of known active infectious diseases,
• Presence of hepatic encephalopathy, Hepantorenal Syndrome
• Presence or history of confirmed or suspected ILD;
• Prior history of significant neurological or mental disorders, including conditions that interfere with assessment, such as epilepsy, dementia, or major depressive disorder.
• Past history of severe allergy, or history of hypersensitivity to any active or inactive ingredient of investigational drugs.
• Presence of any conditions that jeopardize subject safety or interfere with study assessments as judged by the investigator.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07414953 · HS-10504-103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗