Dose Escalation and Expansion Study of HM97662 in Advanced or Metastatic Solid Tumors

Inclusion Criteria:

• Histologically and/or cytologically confirmed advanced or metastatic solid tumor whohave failed/are intolerant to standard therapy.

• Patients for dose-escalation part must have evaluable or measurable disease atbaseline and the patients for randomized dose-ranging and dose-expansion part musthave at least one measurable lesion at baseline by CT or MRI per Response EvaluationCriteria in Solid Tumor (RECIST v1.1).

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Life expectancy ≥ 3 months before starting HM97662.

• Adequate renal function.

• Adequate hematologic function.

• Adequate liver function.

• Males or females aged ≥ 18 years (or country's legal age of majority if the legalage was > 18 years) at the time of informed consent.

• For Dose-Ranging Part, documentation of an alteration in at least one of the genesof the SWI/SNF complex in tumor tissue (archival or newly obtained).

Exclusion Criteria:

• Prior exposure to valemetostat or other EZH1/2 dual inhibitor.

• Known brain metastases that are untreated, symptomatic, or require therapy tocontrol symptoms.

• Patients currently taking medications that are known strong CYP3A inhibitors andstrong or moderate CYP3A inducers.

• Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy)clinically significant toxicities that have not resolved to Grade ≤ 1 per CTCAEversion 5.0 or prior treatment-related toxicities that are clinically unstable andclinically significant at time of enrollment.

• Major surgery within 4 weeks before the first dose of study drug treatment in Cycle

• Females who are pregnant or breastfeeding.

• Patients who have undergone an organ transplant.