A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations

Key Inclusion Criteria:

Subjects are eligible for enrollment into this study if they meet any of the following criteria (NOTE: This is not an exhaustive list):

• Subjects aged ≥18 years.

• ECOG performance status 0 or 1

• Subjects must have a documented IDH mutation per immunohistochemistry (IHC),polymerase chain reaction (PCR), or next generation sequencing (NGS) testing oftumor tissue.

• Subjects must have histologically or cytologically documented, advanced ormetastatic solid malignancy of any type that has recurred or progressed on availablestandard treatment and for which no curative therapy exists.

Key Exclusion Criteria:

Subjects are not eligible for enrollment into this study if they meet any of the following criteria (NOTE: This is not an exhaustive list):

• Subjects who received an investigational agent <14 days prior to their first day ofstudy drug administration

• Subjects who are pregnant or breastfeeding

• Subjects with an active severe infection, some treated infections and with anexpected or with an unexplained fever >38.3°C during screening visits or on theirfirst 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 beeligible

• Subjects with immediately life-threatening, severe complications of leukemia such asuncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminatedintravascular coagulation

• Some subjects with some current or prior gastrointestinal or liver diseases

• Subjects with inadequate organ function as defined by the protocol