A Phase 1 Study to Evaluate FN-1501 Monotherapy in Patients With Advanced Solid Tumors and R/R AML

This is an interventional treatment trial for Advanced Cancer Read More

Inclusion Criteria:

• 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

Exclusion Criteria:

• Participation in another therapeutic clinical trial within 3 weeks of enrollment
• A previous toxicity-related reaction towards cancer therapy have not recovered within 2 weeks of enrollment (>Grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03)
• Having received a major surgical operation within 4 weeks of enrollment or not yet completely recovered from a previous operation
• Any serious or uncontrollable systemic disease, including but not limited to: Hypertension (after treatment, systolic blood pressure (SBP) > 180 mmHg and/or diastolic blood pressure (DBP) > 100 mmHg) and active hemorrhagic disorders; patients who are determined by investigators as otherwise not suitable for participation in this study.Note: Patients that in the judgment of the investigator have clinical signs of disease progression during the screening period (i.e.: febrile neutropenia, ascites requiring drainage, hospitalization due to worsening underlying disease, etc.) will not be eligible for participation.
• 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:
• Any risk which may increase QTc interval prolongation, such as hypokalemia, hereditary long QT syndrome and taking drugs that can prolong QT interval
• Acute myocardial infarction ≤ 6 months prior to Day 1
• Clinically significant arrhythmia ≤ 6 months prior to Day 1
• Congestive heart failure ≥ Grade 3 by New York Heart Association (NYHA) ≤ 6 months prior to Day 1
• Cerebral vascular accident (CVA) ≤ 6 months prior to Day 1
• Are pregnant or breastfeeding