A Study of HMPL-306 in Advanced Hematological Malignancies With mIDH

Exclusion Criteria

• •Subjects who received an investigational agent \<14 days prior to their first day of study drug administration.
• •Subjects who are pregnant or breastfeeding.
• •Subjects with an active severe infection, some treated infections and with an expected or with an unexplained fever \>38.3°C during screening visits or on their first day of study drug administration.
• •Subjects with some current or prior heart conditions.
• •Subjects taking medications that are known to prolong the QT interval may not be eligible.
• •Subjects with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.
• •Some subjects with some current or prior gastrointestinal or liver diseases.
• •Subjects with inadequate organ function as defined by the protocol.
• •Subjects with a medical condition, physical examination finding, or clinical laboratory finding that, in the Investigators opinion, contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the subject at high risk from treatment complications.
• •Subjects with a known hypersensitivity to HMPL-306 or to any of its excipients.
• •Subjects with presence of second primary malignant tumors within the last 2 years, with the exception of the following, if medically controlled: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and carcinoma in situ of the breast.
• •Part 2 Only: The time since the last dose of prior IDH inhibitor treatment is within 30 days prior to the first day of study drug administration