Testing HM16390 for advanced or metastatic solid tumors
A Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study of HM16390, as a Single Agent and in Combination With Pembrolizumab, in Patients With Advanced or Metastatic Solid Tumors
This study is testing a new treatment called HM16390 for people with advanced or metastatic solid tumors who haven't had success with other therapies to see if it can help them.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 292 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hanmi Pharmaceutical Company Limited Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, pembrolizumab |
| Locations | 7 sites (Boston, Massachusetts and 6 other locations) |
| Trial ID | NCT06724016 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial evaluates HM16390, a new treatment for patients with advanced or metastatic solid tumors who have not responded to standard therapies. The study consists of a dose-escalation phase to determine the maximum tolerated dose (MTD) and a dose-expansion phase to assess the efficacy of HM16390 at the recommended phase 2 dose (RP2D). Patients will be monitored for safety, tolerability, pharmacokinetics, and overall effectiveness of the treatment. The trial aims to provide insights into the potential benefits of HM16390 as a single-agent therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed advanced or metastatic solid tumors who have failed or are intolerant to standard therapies.
Not a fit: Patients with known active CNS metastases or those who have previously received treatments targeting IL-2, IL-7, or IL-15 receptors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced or metastatic solid tumors who have limited treatment choices.
How similar studies have performed: While this approach is novel, similar studies targeting advanced solid tumors have shown promise in the past, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Have a histologically and/or cytologically confirmed advanced or metastatic solid tumor and have failed or are intolerant to standard therapy with clinical benefit. * Patients in the Dose-Escalation Part must have evaluable or measurable disease at baseline and the patients for Dose-Ranging and Dose-Expansion Part must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before allocation or randomization. * Age of 18 years or older (or country's legal age of majority if the legal age was \>18 years) * Adequate renal function. * Adequate hematologic function. * Adequate liver function. Key Exclusion Criteria: * Received prior treatment with agent targeting the IL-2, IL-7, or IL-15 receptors, or related to mode of action of HM16390. * Known active CNS metastases and/or carcinomatous meningitis. * History of severe toxicities associated with a prior immunotherapy. * Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 per NCI-CTCAE version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment. * Has ongoing or suspected autoimmune disease. * Known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, immunocompromised patients. * History of chronic liver disease or evidence of hepatic cirrhosis.
Where this trial is running
Boston, Massachusetts and 6 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Not_yet_recruiting)
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Severance Hospital — Seoul, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Active_not_recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Young Su (Bobby) Noh
- Email: 63forever@hanmi.co.kr
- Phone: 82-2-410-9277
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.