A Multicenter, Open-label, Dose Escalation and Expansion, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PB101 in Patients With Advanced Solid Tumor
This clinical trial is designed as a multi-center, open-label, dose-escalation, dose-expansion, phase 1 clinical trial and will be evaluating the safety and efficacy of PB101 in patients with advanced solid tumors who have progressed after standard of care. PB101 may stop the growth of tumor cells by blocking blood flow to the tumor and modulating the tumor microenvironment.
∙ Subjects must meet all of the following inclusion criteria.
• ≥19 years of age
• Patients with unresectable locally advanced or metastatic solid tumor, confirmed histologically and cytologically, who is refractory to existing standard of care or has progressive disease and has no other available standard of care available.
• Patient who has at least one measurable or non-measurable but evaluable lesion that meets the RECIST version 1.1.
• Patient whose expected survival period is 12 weeks or longer.
• Patient with eastern cooperative oncology group (ECOG) performance status ≤ 2
• Patient whose adequate hematological function, and kidney and liver functions have been confirmed by the following criteria. (Laboratory tests are allowed to re-conducted within the screening period.)
• Patient with adequate anticoagulant functions according to the following criteria:
‣ Without receiving anticoagulant therapy, patient whose international normalized ratio (INR) is ≤ 1.5 x upper limit of normal (ULN) and partial thromboplastin time (PTT) is ≤ 5 seconds above the ULN.
⁃ When receiving an oral anticoagulant or low molecular weight heparin, patient whose prothrombin time (PT) or PTT is confirmed to be stable for at least 2 weeks.
⁃ When receiving warfarin, patient whose INR is ≤3.0 There must be no active bleeding (bleeding within 14 days) or pathological conditions with a high risk of bleeding (e.g., tumor with macrovesicular invasion or known varicose vein).
• Patient who voluntarily gave informed consent in writing to participate in this clinical trial after being provided with information on the nature and risks of the study as well as the expected desirable benefits and AEs of the investigative product (IP).