Evaluate Safety, Tolerability, PK, Preliminary Clinical Activity of OB318 in Patients With Advanced Solid Malignancies

Inclusion Criteria

• •1. Male or female patients of age ≥20 years
• •2. Pathologically or cytologically confirmed advanced solid tumors for which standard therapy proven to provide clinical benefit does not exist or is no longer effective; the diagnosis of hepatocellular carcinoma (HCC) made according to the imaging specified in the American Association for the Study of Liver Diseases (AASLD) 2018 is acceptable.
• •3. Evaluable disease, either at least one measurable untreated target lesion on imaging by RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria or measurable by informative tumor marker(s).
• •4. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.
• •5. Life expectancy ≥ 3 months.
• •6. If history of brain metastases treated with radiation therapy, radiation therapy is required to be completed at least 3 months prior to enrolment and metastasis achieve stable disease (SD) since radiation completion.
• •7. Must have recovered from toxicities of previous anti-cancer treatments to NCI-CTCAE grade 1 or lower, except for alopecia.
• •8. Laboratory values at screening of:
• •* Absolute neutrophil count ≥ 1,500 /mm3;
• •* Platelets ≥ 75,000 /mm3;
• •* Hemoglobin (Hb) ≥ 8.5 g/dL;
• •* Total bilirubin ≤2.0 mg/dL;
• •* AST (SGOT) ≤ 3 × ULN (upper limit of normal);
• •* ALT (SGPT) ≤ 3 × ULN;
• •* Serum creatinine ≤1.5 mg/dL or a measured creatinine clearance ≥ 60 mL/min.
• •9. Patients with primary liver cancer or hepatic metastasis are eligible to enroll, provided that, at screening, the following criteria are met:
• •* Total bilirubin ≤2.0 mg/dL;
• •* AST and ALT ≤ 5 × ULN;
• •* Child-Pugh Class A;
• •* Patients with a history of esophageal bleeding have varices that have been sclerosed or banded and no bleeding episodes have occurred during the prior 6 months.
• •10. Female patients must be either of non-childbearing potential, i.e. surgically sterilized or one year post-menopausal; or, if of childbearing potential, confirmed not pregnant at screening and must use adequate contraceptive precautions (as per investigator) during the entire treatment period of this study and for 6 months after exiting from the study.
• •11. Male patients with female partners of childbearing potential must be willing to use a reliable form of contraception (as per investigator), from screening until 6 months after exiting from the study.
• •12. Given signed and dated written informed consent and willing/able to comply with all protocol required visits/procedures