Actively Recruiting
Phase IBII Study of Injectable SHR-A1811 Combined With Pyrotinib or SHR-1316 to Treat Advanced Non-small Cell Lung Cancer with HER2
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-04-20
324
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of the injectable drug SHR-A1811 in combination with other antitumor therapies for adults with advanced non-small cell lung cancer that has a HER2 biomarker. This open, multicenter Phase IBII clinical trial includes a dose-increasing design to study the treatment combinations and their effects on this serious condition. The trial has two parts Part A tests SHR-A1811 combined with the oral drug Pyrotinib, and Part B tests SHR-A1811 combined with the intravenous drug SHR-1316. SHR-A1811 is given intravenously in both parts. The study explores different dose levels to find suitable combinations and observe their impact. Participants will be monitored closely throughout the study, with assessments including tumor response, adverse events, and antibody levels related to SHR-A1811 and the combined drugs. The main outcomes measured are dose-limiting toxicities, serious adverse events, and objective response rate, with follow-up extending up to two years after the last participant enrolls. Various laboratory tests and blood samples will be collected to track the drugs behavior and immune responses during the study.
CONDITIONS
Brief Title
A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer
Research Team
S
Suqiang Yu
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