Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activity of FN-1501 Monotherapy in Patients With Advanced Solid Tumors

This is a phase 1, first-in-human, open-label, multicenter, dose escalation study.

Dose escalation will follow the traditional 3+3 design. Patients will be screened for
eligibility for up to 28 days prior to entry into the study. The starting dose will be 2.5
mg/day (once daily). The period for DLT assessment is 21 days from the first dose of FN-1501.
Evaluation of a cohort of at least three (3) patients completing DLT assessment at any given
dose level is required prior to determining the next dose level and dose regimen for the
subsequent cohort.

After the first patient in the cohort receives the Cycle 1, Day 1 dose, subsequent patients
in that cohort will not be dosed until the first patient has been evaluated for at least 48
hours to exclude unexpected acute toxicity. The continuous safety evaluation will be
performed by investigators, the medical monitor, and the sponsor. A Safety Monitoring
Committee (SMC) will determine dose levels to be administered and dose regimen during dose
escalation based on the data available from the previous dose levels. If an MTD is not
identified due to paucity of DLTs, the RP2D will be determined based on pharmacokinetics,
safety, tolerability, and preliminary efficacy.

If a patient wishes to continuously receive study treatment on completion of Cycle 1, the
patient can continue study treatment in 21-day Cycle 2 and subsequent cycles (same as Cycle
2, all of 21 days' duration), defined as administration of 3 times per week for 2 weeks
followed by 1 week rest, at the discretion of the investigator.

The primary endpoint of this study is to determine the recommended phase 2 dose (RP2D) of
FN-1501 based on pharmacokinetics, safety and tolerability, as well as preliminary efficacy.

Inclusion Criteria:

- Male and female of 18 years old and above

- Able to understand and sign consent form

- Patients with histologically or cytologically confirmed advanced solid tumors who have
relapsed or refractory disease for which no standard therapies expected to produce
clinical benefit to the patient are available

- Patients with diagnosed solid tumors must have at least one lesion that is measurable
per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

- Have discontinued all previous cancer therapies for at least 21days or 5 half-lives
prior to study treatment, whichever is shorter, and recovered from the acute adverse
effects of therapy

- Expected survival of at least 2 months

- LVEF ≥ 50% and QTc interval < 450 ms

- Women shall meet either of the following conditions before enrollment

- Infertile, defined as having a bilateral oophorectomy (ovariectomy), or a bilateral
tubal ligation, or being post-menopausal for at least 1 year.

- For those of childbearing potential, they should have a negative serum pregnancy test
during screening, agree to refrain from lactation, and use effective contraception
such as hormonal methods associated with inhibition of ovulation, condom,
intra-uterine device, surgical sterilization (including partner's vasectomy) or sexual
abstinence during the study and 30 days after the last administration of study drug.

- Men who are engaging or plan to engage in sexual activity with a female of
childbearing potential must either have a prior vasectomy or agree to use effective
contraception such as condoms, sexual abstinence and appropriate methods taken by
their partners during the study and 90 days after the last dose.

- Patients must have adequate organ functions as indicated by the following screening
laboratory values:

- Serum total bilirubin ≤ 1.5 × upper limit normal (ULN) (Serum total bilirubin can be ≤
3.0 × ULN if patients have hemolysis or congenital hemolytic diseases)

- Creatinine < 1.5 × ULN or estimated creatinine clearance ≥ 50 mL/min

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN or

- 5 X ULN for patient with liver metastases

- Absolute neutrophil count (ANC) ≥ 1.5×10^9/L

- Platelets ≥ 100×10^9/L

- Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L (Note: Criteria must be met without a transfusion
within 2 weeks of obtaining the sample)

Exclusion Criteria:

- Participation in another therapeutic clinical trial within 3 weeks of enrollment

- Previous toxic reactions to cancer therapy and have not recovered within 2 weeks of
enrollment (> NCI CTCAE 4.03 Grade 2)

- Having received a major surgical operation within 4 weeks of enrollment or not
completely recovered from a previous operation

- Any serious or uncontrollable systemic disease, including but not limited to:
Hypertension (after treatment, systolic pressure > 180 mmHg and/or diastolic pressure
> 100 mmHg) and active hemorrhagic disorders; patients who are determined by
investigators as otherwise not suitable for participation in this study

- Active known infection, including hepatitis B, hepatitis C, and human immunodeficiency
virus

- Primary central nervous system (CNS) tumor or CNS metastases, as indicated by clinical
symptoms, cerebral edema, and/or progressive growth (patients with a history of CNS
metastases or cord compression are allowable if they have been definitively treated
and have been clinically stable for at least 3 months, and off steroids or
anticonvulsants ≥ 2 weeks before first dose of study drug)

- Serious kidney injury, requiring dialysis

- Serious liver injury, and advanced liver diseases of Child-Pugh class B and C

- On medications that are strong cytochrome P450(CYP)3A inhibitors or inducers unless
patients are willing and able to change to use of an equivalent medication that is not
a strong CYP3A inhibitor or inducer

- Cardiac function and disease history which meets one or more of the following
conditions