Advanced or Metastatic Solid Tumors Clinical Trial
Official title:
A Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study of HM97662 as a Single Agent in Patients With Advanced or Metastatic Solid Tumors
This is a Phase1 study to assess the safety, PK, PD and efficacy of HM97662, EZH1/2 dual inhibitor, in solid tumors. The study will be conducted in Dose-Escalation and Dose-Expansion parts. Dose-Escalation Part is planned with a 3+3 Dose-Escalation design and is to establish the MTD or RD for Dose-Expansion part of HM97662 as a single agent in subjects with advanced or metastatic solid tumors. Dose-Expansion Part is designed to assess the potential efficacy of HM97662 monotherapy when administered at the RD to subjects in indication-specific expansion cohorts.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | June 2028 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 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. 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Cancer Research SA | Adelaide | |
Australia | Grampians Health | Ballarat | |
Australia | Monash Medical Centre | Clayton | |
Australia | Peninsula and Southeast Oncology | Frankston | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Seoul National University Bundang Hospital | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | The Catholic University of Korea, Seoul ST. Mary's Hospital. | Seoul |
Lead Sponsor | Collaborator |
---|---|
Hanmi Pharmaceutical Company Limited |
Australia, Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and nature of DLTs | Days 1-28 of Cycle 1 (DLT assessment period) in Dose-Escalation Part | ||
Primary | Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI CTCAE v5.0 | until Safety Follow-up, 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first | ||
Secondary | Area under the concentration-time curve (AUC) | until Cycle 4 Day1 (each cycle is 28 days) | ||
Secondary | The maximum plasma concentration (Cmax) | until Cycle 4 Day1 (each cycle is 28 days) | ||
Secondary | Trough plasma concentration (Ctrough) | until Cycle 4 Day1 (each cycle is 28 days) | ||
Secondary | Time to reach Cmax (Tmax) | until Cycle 4 Day1 (each cycle is 28 days) | ||
Secondary | Terminal Half-life (T1/2) | until Cycle 4 Day1 (each cycle is 28 days) | ||
Secondary | Apparent clearance (CL/F) | until Cycle 4 Day1 (each cycle is 28 days) | ||
Secondary | Apparent volume of distribution (Vd/F) | until Cycle 4 Day1 (each cycle is 28 days) | ||
Secondary | Objective response | Day 1 of Cycles 3, 5, 7 (each cycle is 28 days) and further (every 8 weeks) until disease progression (assessed up to 5 years) |
Status | Clinical Trial | Phase | |
---|---|---|---|
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