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Trial Title:
Dose Escalation and Expansion Study of HM97662 in Advanced or Metastatic Solid Tumors
NCT ID:
NCT05598151
Condition:
Advanced or Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HM97662
Description:
To evaluate the safety, tolerability, preliminary anti-tumor efficacy, PK and PD of
HM97662 in solid tumors
Arm group label:
HM97662
Summary:
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.
Criteria for 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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Research SA
Address:
City:
Adelaide
Country:
Australia
Status:
Recruiting
Facility:
Name:
Grampians Health
Address:
City:
Ballarat
Country:
Australia
Status:
Recruiting
Facility:
Name:
Monash Medical Centre
Address:
City:
Clayton
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peninsula and Southeast Oncology
Address:
City:
Frankston
Country:
Australia
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea, Seoul ST. Mary's Hospital.
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Start date:
January 11, 2023
Completion date:
June 2028
Lead sponsor:
Agency:
Hanmi Pharmaceutical Company Limited
Agency class:
Industry
Source:
Hanmi Pharmaceutical Company Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05598151
