This is a multi-center , open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of HYP-6589 in monotherapy in advanced solid tumors and combination with tyrosine kinase inhibitors in patients with advanced NSCLC with target-driven gene positivity.
Voluntarily sign an informed consent form, understand the study and be willing and able to follow and complete all trial procedures;
≥18 years old and ≤80 years old, gender: male or female;
Histological or cytological confirmation of unresectable and/or metastatic advanced solid tumors;
At least one measurable lesion (according to RECIST 1.1 version);
Participants who have received other investigational drugs or participated in interventional medical device studies within 4 weeks prior to the first administration of the study drug;
Participants who have received (attenuated) live vaccines within 4 weeks prior to the first administration of the study drug;
Participants who have undergone major organ surgery (excluding biopsy) within 4 weeks prior to the first administration of the study drug or have experienced significant trauma, or who require elective major organ surgery (excluding biopsy) during the study period;
Participants who, based on computerized tomography (CT) or magnetic resonance imaging (MRI) examinations conducted during the screening period and before radiological assessment, have uncontrolled, unstable, or active central nervous system (CNS) metastases;