A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age range: 18-75 years old (including both ends), gender is not limited. 2. Subjects with locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology as unsuitable for radical surgery or radiotherapy treatment 3. ECOG score is 0 or 1 4. Expected survival period ≥ 12 weeks 5. According to the RECIST v1.1 standard, there must be at least one measurable lesion. 6. Good level of organ function 7. The patient voluntarily joined this study and signed informed consent 8. Left ventricular ejection fraction (LVEF) ≥ 50% Exclusion Criteria: 1. Suffering from other malignant tumors within the past 5 years 2. Subjects with active central nervous system (CNS) tumor metastasis, a history of meningeal metastasis, or current meningeal metastasis 3. Patients with uncontrollable tumor related pain 4. Has serious cardiovascular and cerebrovascular diseases 5. Significant clinically significant bleeding symptoms occurred within 3 months prior to the