A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer

Официальное название

An Open Label, Multicenter Phase II Clinical Study on the Safety, Tolerability, and Efficacy of FH-006 Injection Combined With Other Anti-tumor Therapies in Lung Cancer Subjects

Обзор

Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in combination with other anti-tumor treatments in lung cancer subjects, and determine the recommended dose (RP2D) and initial efficacy for phase II clinical trials.

Вмешательства

• Препарат FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin
  FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin
• Препарат FH-006 ; SHR-1316 ; BP102
  FH-006 ; SHR-1316 ; BP102
• Препарат FH-006; SHR-1316 ; SHR-8068
  FH-006; SHR-1316 ; SHR-8068

Первичные конечные точки

• DLT (Dose-limiting toxicity)：Severe toxicity occurred 21 or 28 days after each subject received their first systemic anticancer treatment. [Срок оценки: 21or28 days after the first administration of each subject]
• Incidence of Treatment-Emergent Adverse Events [Срок оценки: from first dose to disease progression or death, up to 3 years.]
• RP2D (Recommended Phase II Dose)：This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics. [Срок оценки: from first dose to disease progression or death, up to 3 years]
• ORR (Objective Response Rate) [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]

Вторичные конечные точки (4)

• Duration of response (DoR) [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]
• disease control rate (DCR) [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]
• progression free survival (PFS) [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]
• overall survival (OS) [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]

Критерии участия

Критерии включения

• Age range: 18-75 years old (including both ends), gender is not limited.
• Subjects with locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology as unsuitable for radical surgery or radiotherapy treatment
• ECOG score is 0 or 1
• Expected survival period ≥ 12 weeks
• According to the RECIST v1.1 standard, there must be at least one measurable lesion.
• Good level of organ function
• The patient voluntarily joined this study and signed informed consent
• Left ventricular ejection fraction (LVEF) ≥ 50%

Критерии исключения

• Suffering from other malignant tumors within the past 5 years
• Subjects with active central nervous system (CNS) tumor metastasis, a history of meningeal metastasis, or current meningeal metastasis
• Patients with uncontrollable tumor related pain
• Has serious cardiovascular and cerebrovascular diseases
• Significant clinically significant bleeding symptoms occurred within 3 months prior to the first study medication
• Uncontrollable third interstitial fluid accumulation within 2 weeks of initial study medication
• History of clinically significant pulmonary diseases
• Receive other anti-tumor treatments within 4 weeks before the first medication
• Severe infection within 4 weeks before the first medication
• Active, known or suspected autoimmune diseases, and a history of autoimmune diseases.
• History of immunodeficiency
• Individuals with active pulmonary tuberculosis infection within the year prior to enrollment
• Chest radiation therapy patients who received>30 Gy within 24 weeks prior to the first use of the investigational drug
• The adverse reactions of previous anti-tumor treatments have not yet recovered to ≤ Grade I
• Surgical treatment of important organs within 4 weeks prior to the first use of medication
• Use attenuated live vaccine within 28 days prior to the first use of the investigational drug
• There are other serious physical or mental illnesses or laboratory abnormalities present
• Pregnant, lactating women, or female participants who plan to become pregnant within 14 months after the last use of the investigational drug during the study period
• Having bleeding tendency, high risk of bleeding, coagulation dysfunction or thrombophilia tendency
• Previously experienced hypertensive crisis or hypertensive encephalopathy
• Suffering from significant vascular disease within 6 months prior to the first use of medication
• Have undergone a biopsy or other minor surgery within 7 days prior to the first use of medication
• Having severe, unhealed wounds, active ulcers, or untreated fractures
• Gastrointestinal perforation occurred within 6 months prior to the first use of medication
• 24-hour proteinuria quantification ≥ 1g within 7 days before the first medication
• CT/MRI indicates tumor surrounding or invading large blood vessels

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

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07241767 · FH-006-201-LC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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