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Dosisescalatie- en uitbreidingsstudie van HM16390 bij gevorderde of gemetastaseerde solide tumoren

2 november 2026 bijgewerkt door: Hanmi Pharmaceutical Company Limited

Een fase I, open-label, multicenter, dosis-escalatie- en uitbreidingsstudie van HM16390 bij patiënten met gevorderde of gemetastaseerde solide tumoren

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

292

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • California
      • Los Angeles, California, Verenigde Staten, 90095
        • Werving
        • The Regents of the University of California on behalf of its Los Angeles campus
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02114
        • Werving
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, Verenigde Staten, 48201
        • Werving
        • Karmanos Cancer Institute
  • Zuid -Korea
      • Seoul, Zuid -Korea, 03080
        • Werving
        • Seoul National University Hospital
      • Seoul, Zuid -Korea, 06351
        • Werving
        • Samsung Medical Center
      • Seoul, Zuid -Korea, 03722
        • Werving
        • Severance Hospital
      • Seoul, Zuid -Korea, 05505
        • Actief, niet wervend
        • Asan Medical Center
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Zuid -Korea, 13620
        • Werving
        • Seoul National University Bundang Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: HM16390

HM16390 Monotherapy
Geneesmiddel: HM16390

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

HM16390 in combination with pembrolizumab
Geneesmiddel: pembrolizumab

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

Andere namen:
  • KEYTRUDA®
Geneesmiddel: HM16390

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence and nature of DLTs
Tijdsspanne: 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
At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
Tijdsspanne: 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
Throughout the study until end of safety follow-up period (90 days after the last treatment)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective response rate (ORR)
Tijdsspanne: 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
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
Disease Control Rate (DCR)
Tijdsspanne: 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
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
The maximum serum concentration (Cmax)
Tijdsspanne: Throughout the study until treatment discontinuation (up to 2-3 years)

To evaluate PK profile upon HM16390 administration
Throughout the study until treatment discontinuation (up to 2-3 years)
The time to reach Cmax (Tmax)
Tijdsspanne: Throughout the study until treatment discontinuation (up to 2-3 years)

To evaluate PK profile upon HM16390 administration
Throughout the study until treatment discontinuation (up to 2-3 years)
The area under the concentration-time curve from time 0 to the last observable concentration (AUClast)
Tijdsspanne: Throughout the study until treatment discontinuation (up to 2-3 years)

To evaluate PK profile upon HM16390 administration
Throughout the study until treatment discontinuation (up to 2-3 years)
The AUC extrapolated to infinity (AUCinf)
Tijdsspanne: Throughout the study until treatment discontinuation (up to 2-3 years)

To evaluate PK profile upon HM16390 administration
Throughout the study until treatment discontinuation (up to 2-3 years)
The AUC during the dosing interval (AUCtau)
Tijdsspanne: Throughout the study until treatment discontinuation (up to 2-3 years)

To evaluate PK profile upon HM16390 administration
Throughout the study until treatment discontinuation (up to 2-3 years)
The serum concentration at the end of the dosing interval (Ctrough)
Tijdsspanne: Throughout the study until treatment discontinuation (up to 2-3 years)

To evaluate PK profile upon HM16390 administration
Throughout the study until treatment discontinuation (up to 2-3 years)
The elimination half-life (T1/2)
Tijdsspanne: Throughout the study until treatment discontinuation (up to 2-3 years)

To evaluate PK profile upon HM16390 administration
Throughout the study until treatment discontinuation (up to 2-3 years)
The apparent volume of distribution (Vd/F)
Tijdsspanne: Throughout the study until treatment discontinuation (up to 2-3 years)

To evaluate PK profile upon HM16390 administration
Throughout the study until treatment discontinuation (up to 2-3 years)
The apparent clearance (CL/F)
Tijdsspanne: Throughout the study until treatment discontinuation (up to 2-3 years)

To evaluate PK profile upon HM16390 administration
Throughout the study until treatment discontinuation (up to 2-3 years)
Progression-free survival (PFS)
Tijdsspanne: 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
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
Duration of response (DOR)
Tijdsspanne: 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.
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hanmi Pharmaceutical Company Limited

Medewerkers

Merck Sharp & Dohme LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 december 2024

Primaire voltooiing (Geschat)

1 juli 2031

Studie voltooiing (Geschat)

1 juli 2031

Studieregistratiedata

Eerst ingediend

29 november 2024

Eerst ingediend dat voldeed aan de QC-criteria

6 december 2024

Eerst geplaatst (Werkelijk)

9 december 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HM-LIL2-101
  • KEYNOTE-G39 (Andere identificatie: Merck & Sharp Dohme LLC)
  • MK-3475-G39 (Andere identificatie: Merck & Sharp Dohme LLC)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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