Testing HM16390 for advanced or metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Regents of the University of California on behalf of its Los Angeles campus
  Los Angeles, California, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Karmanos Cancer Institute
  Detroit, Michigan, United States 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

Study contacts

• Study coordinator: Hyebin Son
• Email: hyebin.son@hanmi.co.kr
• Phone: 82-2-410-9835

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.