A Phase Ib/II Study of AK138D1 as Monotherapy and in Combination With Ivonescimab in Patients With Advanced Non-Small Cell Lung Cancer
The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of AK138D1 as monotherapy or in combination with ivonescimab in patients with advanced non-small cell lung cancer. Participants will receive study treatment with AK138D1 alone or in combination with ivonescimab, undergo safety assessments and tumor evaluations, and be followed for treatment tolerability, antitumor activity, and clinical outcomes.
• The subject must sign the written informed consent form (ICF) voluntarily;
• At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;
• Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Has a life expectancy of ≥ 3 months;
• Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Has Stage IIIB/IIIC or IV non-small cell lung cancer (NSCLC) (American Joint Committee on Cancer \[AJCC\]).
• Adequate organ function.