Dose Escalation and Expansion Study of HM16390 in Advanced or Metastatic Solid Tumors

Launched by HANMI PHARMACEUTICAL COMPANY LIMITED · Dec 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HM16390 for patients with advanced or metastatic solid tumors, which are cancers that have spread from their original site to other parts of the body. The trial is in its early phase (Phase 1) and aims to find out how safe HM16390 is, what the best dose is, and how well it works. Participants will first receive increasing doses of the drug to determine the highest dose they can tolerate without serious side effects. After this, more patients will be enrolled to receive specific doses to further assess the drug's effectiveness.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of advanced or metastatic solid tumors that have not responded to standard treatments. They should also have measurable disease that can be tracked using imaging tests like CT scans or MRIs. Participants can expect to be closely monitored throughout the study for any side effects and to see how well the treatment is working. It's important to note that certain conditions, such as severe liver disease or ongoing infections, may prevent someone from joining the trial. This study is actively looking for new participants who meet the criteria.

Gender

ALL

Eligibility 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.
• • 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 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.