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NCT06724016

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Hanmi Pharmaceutical Company Limited
~292 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:HM16390pembrolizumab

At a glance

Recruiting sites
5 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and nature of DLTs
Measured over At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
+1 more outcome measured

Conditions

Advanced or Metastatic Solid Tumors

Explore related trials

Solid Neoplasm

NCT06724016

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Karmanos Cancer Institute

    Detroit, Michiganno site contact published

    Not yet recruiting

  • Massachusetts General Hospital

    Boston, Massachusettsno site contact published

    Recruiting

  • Samsung Medical Center

    Seoul, South Koreano site contact published

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, South Koreano site contact published

    Recruiting

  • Seoul National University Hospital

    Seoul, South Koreano site contact published

    Recruiting

  • Severance Hospital

    Seoul, South Koreano site contact published

    Recruiting

  • Asan Medical Center

    Seoul, South Koreano site contact published

    Active, not recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Young Su (Bobby) Noh
[email protected]
82-2-410-9277
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Incidence and nature of DLTsAt the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part

    To evaluate safety and tolerability of HM16390 as a single agent and in combination with pembrolizumab

  • Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.Throughout the study until end of safety follow-up period (90 days after the last treatment)

    To evaluate safety and tolerability of HM16390 as a single agent, and in combination with pembrolizumab