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

Launched by HANMI PHARMACEUTICAL COMPANY LIMITED · Oct 24, 2022

Keywords

ClinConnect Summary

This clinical trial is testing a new drug called HM97662, which is designed to treat advanced or metastatic solid tumors—these are types of cancer that have spread beyond their original site. The study has two main parts: the first part will gradually increase the dose of the drug to find the safest and most effective level, and the second part will look at how well the drug works at that established dose in specific groups of patients. The trial is currently recruiting participants, and anyone aged 18 years or older with confirmed advanced cancer that hasn’t responded to other treatments may be eligible.

Participants in this trial can expect to receive HM97662 and will be monitored closely for any side effects and how well the treatment is working. To join, they need to have measurable cancer that can be assessed by scans, and they should be in relatively good health overall. However, certain individuals, such as those with untreated brain metastases or those who have recently had major surgery, cannot participate. This trial represents an opportunity for patients who have limited treatment options to potentially benefit from a new therapy while contributing to important medical research.

Gender

ALL

Eligibility criteria

• 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.