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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05598151
Recruitment Status : Recruiting
First Posted : October 28, 2022
Last Update Posted : June 15, 2023
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors Drug: HM97662 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 11, 2023
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : June 2028

Arm Intervention/treatment
Experimental: HM97662
Tablet, oral administration, once daily (QD), continuous dosing
Drug: HM97662
To evaluate the safety, tolerability, preliminary anti-tumor efficacy, PK and PD of HM97662 in solid tumors




Primary Outcome Measures :
  1. Incidence and nature of DLTs [ Time Frame: Days 1-28 of Cycle 1 (DLT assessment period) in Dose-Escalation Part ]
  2. Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI CTCAE v5.0 [ Time Frame: 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 Outcome Measures :
  1. Area under the concentration-time curve (AUC) [ Time Frame: until Cycle 4 Day1 (each cycle is 28 days) ]
  2. The maximum plasma concentration (Cmax) [ Time Frame: until Cycle 4 Day1 (each cycle is 28 days) ]
  3. Trough plasma concentration (Ctrough) [ Time Frame: until Cycle 4 Day1 (each cycle is 28 days) ]
  4. Time to reach Cmax (Tmax) [ Time Frame: until Cycle 4 Day1 (each cycle is 28 days) ]
  5. Terminal Half-life (T1/2) [ Time Frame: until Cycle 4 Day1 (each cycle is 28 days) ]
  6. Apparent clearance (CL/F) [ Time Frame: until Cycle 4 Day1 (each cycle is 28 days) ]
  7. Apparent volume of distribution (Vd/F) [ Time Frame: until Cycle 4 Day1 (each cycle is 28 days) ]
  8. Objective response [ Time Frame: 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05598151


Contacts
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Contact: Jiyeon Yoon 82-2-410-0368 mush1223@hanmi.co.kr

Locations
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Australia
Cancer Research SA Recruiting
Adelaide, Australia
Grampians Health Recruiting
Ballarat, Australia
Monash Medical Centre Recruiting
Clayton, Australia
Peninsula and Southeast Oncology Recruiting
Frankston, Australia
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seoul, Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital. Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT05598151    
Other Study ID Numbers: HM-EZHI-101
First Posted: October 28, 2022    Key Record Dates
Last Update Posted: June 15, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms