This trial is a first-in-human, multicenter, open-label Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of KY-0301 as monotherapy in patients with advanced solid tumors. This trial will be conducted at approximately multi-sites nationwide, and approximately110\~212 participants with unresectable locally advanced or metastatic solid tumors will be invited to participate. The study consists of three parts: Phase I dose escalation \& dose expansion phases of KY-0301 as monotherapy, Phase II cohort expansion phase of KY-0301 as monotherapy.
Know the trial information before the start of the study and voluntarily sign an informed consent form (ICF).
Aged ≥ 18 years, male or female.
Agree to follow and be capable of completing all study procedures.
Female weight > 45 kg, male weight > 50 kg, with a BMI ≥18 kg/m2
History of intolerance to ADC therapy composed of monomethyl auristatin E (MMAE).
Inadequate washout period of prior antitumor therapy prior to the first dose
Patients who have undergone major surgery (excluding diagnostic surgery) within 4 weeks prior to first dose or those who plan to undergo major surgery during the study period. Interventional or ablative procedures for tumor treatment within 2 weeks prior to the first dose of the investigational drug.
Previous allogeneic bone marrow transplantation or previous solid organ transplantation.