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;
Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
Presence of active central nervous system (CNS) metastases.
Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;
Untreated subjects with active hepatitis B or active hepatitis C;