Testing HM97662 for advanced or metastatic solid tumors

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 study is testing a new drug called HM97662 to see if it can help people with advanced or metastatic solid tumors who haven't had success with other treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hanmi Pharmaceutical Company Limited (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 10 sites (Adelaide and 9 other locations)
• Trial ID: NCT05598151 on ClinicalTrials.gov

What this trial studies

This Phase 1 study evaluates the safety, pharmacokinetics, pharmacodynamics, and efficacy of HM97662, a dual inhibitor of EZH1/2, in patients with advanced or metastatic solid tumors. The study consists of a dose-escalation phase to determine the maximum tolerated dose (MTD), followed by a randomized dose-ranging phase to assess safety and preliminary efficacy in patients with specific genomic alterations. Finally, a dose-expansion phase will evaluate the efficacy of HM97662 at the recommended phase 2 dose (RP2D) in specific cohorts. The study aims to provide insights into the therapeutic potential of HM97662 for patients who have not responded to standard treatments.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced or metastatic solid tumors that have failed or are intolerant to standard therapies and have specific genomic alterations.

Not a fit: Patients who have not experienced treatment failure or intolerance to standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for patients with advanced or metastatic solid tumors who have limited alternatives.

How similar studies have performed: Other studies involving EZH1/2 inhibitors have shown promise, indicating potential for success with this approach.

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.

Where this trial is running

Adelaide and 9 other locations

• Cancer Research SA — Adelaide, Australia (RECRUITING)
• Grampians Health — Ballarat, Australia (RECRUITING)
• Monash Medical Centre — Clayton, Australia (RECRUITING)
• Peninsula and Southeast Oncology — Frankston, Australia (RECRUITING)
• National Cancer Center — Goyang-si, Gyeonggi-do, South Korea (NOT_YET_RECRUITING)
• Asan Medical Center — Seoul, South Korea (RECRUITING)
• Samsung Medical Center — Seoul, South Korea (NOT_YET_RECRUITING)
• Seoul National University Bundang Hospital — Seoul, South Korea (RECRUITING)
• Seoul National University Hospital — Seoul, South Korea (RECRUITING)
• The Catholic University of Korea, Seoul ST. Mary's Hospital — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Jiyeon Yoon

Conditions: Advanced or Metastatic Solid Tumors