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New treatment option for Advanced or Metastatic Solid Tumors
Official title Dose Escalation and Expansion Study of HM97662 in Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT05598151
What this study is testing
What is HM97662?
HM97662 is an investigational medicine, being studied as a potential treatment for advanced or metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase1 study to assess the safety, PK, PD and efficacy of HM97662, EZH1/2 dual inhibitor, in solid tumors. The study is comprised of Dose-Escalation Part followed by randomized Dose-Ranging Part and Dose-Expansion Part.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 assigned by chance dose-ranging and...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 3 months before starting HM97662.
- Adequate renal function.
You likely can't join if
- 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...
- Major surgery within 4 weeks before the first dose of study drug treatment in Cycle 1.
- Females who are pregnant or breastfeeding.
See the full eligibility 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 assigned by chance dose-ranging and dose-expansion part must have at least one measurable lesion at baseline...
- 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).
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, Australia
- Ballarat, Australia
- Clayton, Australia
- Frankston, Australia
- Goyang-si, Gyeonggi-do, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, Australia; Ballarat, Australia; Clayton, Australia; Frankston, Australia; Goyang-si, Gyeonggi-do, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.