Phase IB/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer With HER2
This study was an open, multicenter, dose-increasing/investigational Phase IB/II clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811 combined with Pyrotinib, and Part B is the dose escalation and efficacy exploration study of SHR-A1811 combined with SHR-1316.
• Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements
• When signing the informed consent, the age is 18-75 years old (including both ends), and there is no gender limitation
• The ECOG score is 0 or 1
• The expected survival is ≥12 weeks
• Subjects with advanced or metastatic non-small cell lung cancer
• Formalin fixed, paraffin-embedded tumor tissue blocks or sections of unstained tumor specimens are provided
• Subjects who have failed prior standard care or are intolerant to standard care
• There is at least one measurable lesion
• Vital organs are functioning well
⁃ Heart function is good
⁃ Agree to birth control