This phase I trial is evaluating the safety of a drug (FN-1501) in patients with advanced solid tumoursStudy to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activity of FN-1501 Monotherapy in Patients With Advanced Solid Tumors

Inclusion

• Male and female 18 years old and above
• Able to understand and sign informed consent form
• Patients with histologically or cytologically confirmed advanced solid tumors who have relapsed or refractory disease or relapsed/refractory AML 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
• Patients with relapsed or refractory AML must be diagnosed with AML based on World Health Organization (WHO) criteria (≥ 20% blasts in bone marrow). Patients with acute promyelocytic leukemia are excluded
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• Have discontinued all previous cancer therapies for at least 21 days or 5 half-lives prior to study treatment, whichever is shorter, and recovered from the acute adverse effects of therapy
• Expected to survive at least 2 to 3 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 partner(s) 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) Note: Laboratory requirements for complete blood counts (hemoglobin, ANC, and platelets) do not apply to AML patients