Overview

this is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of HYLM-122 monotherapy in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.

Eligibility

Inclusion Criteria:

• Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol.
• Males and/or females at least 18 years old when signing the informed consent form.
• Histologically confirmed AML (defined using WHO criteria 2016) with one of the

  following

        Refractory to at least 1 cycle of induction chemotherapy. Relapsed after achieving
        remission with a prior therapy.
          -  Subject is positive for FLT3 mutation in bone marrow or blood after completion of the
             subject's last interventional treatment.
          -  Eastern cooperative oncology group performance status (ECOG) ≤2 at screening.
          -  Life expectancy of at least 3 months.
          -  Women of childbearing potential have a negative pregnancy test at baseline and are
             willing to employ an effective method of contraception for the entire duration of
             study treatment and 6 months after the last dose.
        Exclusion Criteria:
          -  Known or suspected allergies to any of the investigational drug composition (HYML-122,
             lactose, hydroxypropyl cellulose, hyposubstituted hydroxypropyl cellulose, silicon
             dioxide, magnesium stearate, titanium dioxide and polyethylene glycol).
          -  Medical history and surgical history excluded according to the protocol.
          -  Any previous medical treatment history exclude from the protocol.
          -  Abnormal laboratory results exclude from the protocol.
          -  Combination of treatments and/or drugs required during the study period and cannot be
             discontinued that excluded from the protocol.
          -  Alcohol abuse within 6 months prior to screening, defined as long-term drinking
             history, generally more than 5 years, equivalent to alcohol quantity ≥40g/d for men,
             ≥20g/d for women, or heavy drinking history within 2 weeks, equivalent to alcohol
             quantity ≥80g/d. alcohol volume (g) conversion formula=alcohol consumption
             (mL)alcohol content (%)0.8.
          -  Abortion less than 30 days prior to screening, pregnant and lactating women (currently
             breast-feeding or less than one year after delivery although not breast-feeding),
             women of childbearing potential who are not guaranteed effective contraception during
             the study, planning pregnancy or donating eggs or sperm within 6 months after the last
             dose.
          -  History of drug abuse or drug addicts.
          -  Subjects may not be able to complete the study duo to poor compliance or other
             reasons, or unsuitable for the study by the investigator's judgment.