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 who have failed/are intolerant to standard therapy.
• Patients for dose-escalation part must have evaluable or measurable disease at baseline and the patients for randomized dose-ranging and dose-expansion part must have at least one measurable lesion at baseline by CT or MRI per Response Evaluation Criteria 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 legal age was > 18 years) at the time of informed consent.
• For Dose-Ranging Part, documentation of an alteration in at least one of the genes of 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 to control symptoms.
• Patients currently taking medications that are known strong CYP3A inhibitors and strong or moderate CYP3A inducers.
• Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 per CTCAE version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment.
• Major surgery within 4 weeks before the first dose of study drug treatment in Cycle 1.
• Females who are pregnant or breastfeeding.
• Patients who have undergone an organ transplant.