Study of FCN-437c in Patients With Advanced Solid Tumors

Exclusion Criteria

• •1. Females during pregnancy or breastfeeding.
• •2. Subjects on any anticancer therapy approved or experimental, including chemotherapy, immune therapy, radiation therapy, hormonal therapy (Exceptions: hormone-replacement therapy, testosterone or oral contraceptives), biologic therapy, within 3 weeks (or 5 half-lives whichever is shorter) prior to initiation of study treatment. Note: Subjects should be recovered from treatment related toxicity resolved to baseline except for residual alopecia.
• •3. Subjects who had prior treatment with a CDK4/6 inhibitor except Hormone receptor (HR)+/Human epidermal growth factor receptor 2 (HER2)- breast cancer patients who may have received CDK4/6 inhibitor as a standard treatment.
• •4. Subjects with history of gastric bypass surgery or banding procedure.
• •5. Subjects who have had major surgery within the 28-days from the screening or subjects who have undergone organ transplant surgery.
• •6. Active hepatitis B (HBV) or hepatitis C (HCV). HBV carriers without active disease (HBV DNA titer \< 1000 cps/mL or 200 IU/mL), or cured HCV (negative HCV RNA test) may be enrolled. Subjects with controlled human immunodeficiency virus (HIV) disease may be eligible.
• •7. Subjects with a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.
• •8. Unresolved toxicities (other than alopecia) from previous anti-cancer therapy defined as toxicities not resolved to NCI CTCAE Version 5.0, Grade ≤ 1.
• •9. Subject who have had severe infection within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose administration.
• •10. Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure New York Heart Association (NYHA) III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 3 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
• •11. A resting ECG with QTcF ≥ 470 msc or the subject has a congenital prolonged QT syndrome or with concomitant medications known to prolong the QT interval.
• •12. Taking a prohibited concomitant medication or inability to follow concomitant medications guidelines
• •13. Any other serious underlying medical (e.g., uncontrolled diabetes mellitus, uncontrolled hypertension, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, severe hearing impairment, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, cardiac conditions), psychiatric, psychological, familial or geographical condition that, in the judgment of the Investigator, may interfere with the planned staging, treatment and follow-up, affect subject compliance or place the subject at high risk from treatment-related complications.