In this first-in-human, muticenter, non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 5 parts (Part 1-5). The purpose of this FIH study is to evaluate the safety and tolerability profile of CBA-1205.
Patients who provide voluntary written informed consent to participate in the study
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of≤1
Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (creatinine: ≤ ULN ×1.5)
Patients who meet the following laboratory criteria of bone marrow function as evidenced by laboratory data obtained within 7 days before enrollment: Neutrophil count;≥1500/μL, Platelet count; ≥75000/μL, Hemoglobin;≥9.0 g/dL.
Patients who have undergone major surgery within 28 days before enrollment
Patients who have received anticancer treatment with surgical therapy, radiation therapy, and/or drug therapy within 14 days before enrollment
Patients who have received anticancer treatment with immune checkpoint inhibitor, etc. within 28 days before enrollment
Patients with Grade 2 or higher concurrent disease or prior therapy-related toxicity