The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB264 in combination with KL-A167 with or without chemotherapy with advanced or metastatic non-small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.
Males or females ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form;
Histologically and cytologically confirmed NSCLC;
Cohort 1: Patients with locally advanced/metastatic NSCLC with wild-type EGFR and negative ALK fusion gene, no or at most one prior line of systemic chemotherapy regimen for advanced or metastatic NSCLC. Cohort 2: Patients with locally advanced/metastatic NSCLC with wild-type EGFR and negative ALK fusion gene, no prior systemic therapy. Cohort 3: Patients with locally advanced/metastatic NSCLC with EGFR activating mutation and negative ALK fusion gene, who have failed previous treatment with EGFR-TKIs.
Provide fresh or archival tumor tissue for biomarker testing and analysis;
Presence of small cell lung carcinoma (SCLC) components in histological pathology;
History of other malignancies;
Presence of metastases to brainstem, meninges and spinal cord, or spinal cord compression;
Presence of active central nervous system (CNS) metastases;