Inclusion
Inclusion Criteria: 1. Patients with histologically or cytologically proven locally unresectable advanced or metastatic solid tumors. Patients must be relapsed or refractory to at least one standard-of-care therapy, and/or have refused standard-of-care therapy.
2. Eastern Cooperative Oncology Group performance status of 0 to 1 at Screening, with an estimated life expectancy of at least 3 months.
3. Disease must have at least 1 assessable (long diameter ≥1 cm) lesion for evaluation of response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
4. Patients with adequate organ and bone marrow function, in the absence of growth factors, including the specific laboratory findings of Absolute neutophil count, platelet count, Haemoglobin, AST, ALT, Serum total Bilirubin, Alkaline phosphatase, prothrombin time, INR or activated partial thromboplastin time, creatinine and albumin.
5. Female Volunteers must be of nonchild bearing potential i.e, surgically sterilised at least 6 weeks before Screening Visit or postmenopausal.
6. Females of childbearing potential must have a negative pregnancy test, agree not to attempt to become pregnant or donate Ova and agree to use contraception from one month prior to Screening until at least 90 days after last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle.
Male Vonuteers:
- Must agree not to donate sperm from signing the ICF until at aleast 90 days after the last dose of the study drug.
- If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception.
- Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.