A Multicenter, Open Label, Phase I Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous SAIT301 in Subjects With Advanced c-MET Positive (+) Solid Tumors Followed by Expansion in Selected Tumor Types

Inclusion Criteria:

1. Aged 18 years or older.
2. Have a histologically or cytologically confirmed advanced solid tumor that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy, or the subject is not a candidate for standard therapy.
3. Tumor positive for c-MET expression as determined by IHC. Results should be available before the subject can proceed in the study.
4. Adequate tumor biopsy material should be available for IHC and fluorescence in situ hybridization (FISH) of c-MET and biomarker analysis at the time of enrollment (formalin-fixed, paraffin-embedded tumor block or 20 fresh cut unstained slides).
5. At least 28 days must have elapsed since the subject's prior systemic therapy, radiotherapy, or any major surgery (excluding diagnostic biopsy or venous access device placement). Surgery requiring local/epidural anesthesia must be completed at least 72 hours before the first administration of SAIT301. For concomitant medications with a known half-life of less than 36 hours (e.g., tyrosine kinase inhibitors), the duration of time since prior therapy can be reduced to 14 days provided any drug-related toxicities have resolved to Grade 1 or better. Hormonal therapy for prostate or breast cancer are allowed during the study.
6. For dose levels 1 to 3, subjects must, at a minimum, have evaluable disease according to RECIST 1.1 guidelines. For dose levels above level 3, subjects must have measureable disease (≥1 cm by spiral computerized tomography \[CT\] or ≥2 cm by standard CT).
7. An ECOG performance status of \<2.
8. Life expectancy of \>12 weeks, as judged by the investigator.
9. Female subjects must not be pregnant or breastfeeding, or at risk to become pregnant during the study. Fertile male and female subjects must agree to use an effective barrier method of birth control to avoid pregnancy from the time of providing informed consent until 90 days after the last administration of SAIT301.
10. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of SAIT301. For the purpose of this study, female subjects of childbearing potential are defined as all female subjects after puberty unless they are postmenopausal for at least 1 year, or are surgically sterile (hysterectomy or bilateral oophorectomy or tubal ligation).
11. Adequate organ function as indicated by the laboratory test results obtained within 7 days prior to the first administration of SAIT301:

    Hematologic: Absolute neutrophil count ≥1.5 x 109/L, platelet count ≥100 x 109/L, and hemoglobin ≥9.0 g/dL.

    Liver function: Serum bilirubin \<2.0 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3 x upper limit of normal (ULN) without liver involvement, or \<5 x ULN with liver involvement.

    Renal: serum creatinine ≤1.5 mg/dL.
12. Willing and able to provide written informed consent and to comply with the protocol, visit schedule, and requirements.

Exclusion Criteria:

Subjects will not be entered in the study for any of the following reasons:

1. Received previous treatment with SAIT301 or a previous drug with c-MET inhibitory activity.
2. Received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 28 days of the first administration of SAIT301 in this study.
3. History of prior allergic reactions to protein therapeutics.
4. Active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant.
5. Symptomatic or untreated central nervous system metastases.
6. Not recovered from acute toxicity of any therapy received prior to enrollment.
7. Received systemic treatment for bacterial infection within 7 days of screening.
8. Positive test results for human immunodeficiency virus (HIV), hepatitis B (core immunoglobulin M antibody and/or surface antigen), or hepatitis C at screening.
9. Any other serious medical condition which in the investigator's opinion would preclude safe participation in the study.
10. Likely to be non-compliant or uncooperative during the study, as judged by the investigator.