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NCT Number: NCT06724016

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

This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of HM16390, as a single agent and in combination with pembrolizumab to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors.

Dose-Escalation Part is planned to establish the MTD or RDs for the randomized Dose-Ranging Part. Based on the results of the Dose-Escalation Part, additional eligible subjects will be randomized 1:1 into each dose level. After a comprehensive review of available data from both Dose-Escalation Part and Dose-Ranging Part, the RDEs to be tested in the Dose-Expansion Part are determined. Dose-Expansion Part is designed to assess the potential efficacy of HM16390 as a single agent and in combination with pembrolizumab when administered at the RDEs to subjects in indication-specific expansion cohorts.

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Key information

Conditions

Advanced or Metastatic Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HM16390

Drug

HM16390 will be administered subcutaneously using syringes on Day 1 of every 3-week treatment cycle

Pembrolizumab

Drug

Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle

Other names: KEYTRUDA®

Primary outcomes

  1. Incidence and nature of DLTs

    Time frame: At 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

  2. Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.

    Time frame: 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

Secondary outcomes

  1. The maximum serum concentration (Cmax)

    Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)

    To evaluate PK profile upon HM16390 administration

  2. The time to reach Cmax (Tmax)

    Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)

    To evaluate PK profile upon HM16390 administration

  3. The area under the concentration-time curve from time 0 to the last observable concentration (AUClast)

    Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)

    To evaluate PK profile upon HM16390 administration

  4. The AUC extrapolated to infinity (AUCinf)

    Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)

    To evaluate PK profile upon HM16390 administration

  5. The AUC during the dosing interval (AUCtau)

    Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)

    To evaluate PK profile upon HM16390 administration

  6. The serum concentration at the end of the dosing interval (Ctrough)

    Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)

    To evaluate PK profile upon HM16390 administration

  7. The elimination half-life (T1/2)

    Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)

    To evaluate PK profile upon HM16390 administration

  8. The apparent volume of distribution (Vd/F)

    Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)

    To evaluate PK profile upon HM16390 administration

  9. The apparent clearance (CL/F)

    Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)

    To evaluate PK profile upon HM16390 administration

  10. Objective response rate (ORR)

    Time frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)

    ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  11. Disease Control Rate (DCR)

    Time frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)

    DCR will be measured as the proportion of subject with confirmed CR, PR, or Stable Disease (SD) as per RECIST v1.1

  12. Progression-free survival (PFS)

    Time frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)

    PFS will be measured from date of first treatment until date of radiographic progression as per RECIST v1.1 or until death from any cause, whichever occurs first

  13. Duration of response (DOR)

    Time frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)

    DOR will be measured as the time from initial onset of CR or PR to first radiographic progression as per RECIST v1.1 or death from any cause, whichever occurs first.

Study contacts

Contact information is provided by the study sponsor or research team.

Young Su (Bobby) Noh

CONTACT

[email protected]

82-2-410-9277

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Dec 9, 2024
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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