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RecruitingInterventionalPhase 1

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

NCT ID: NCT06724016Sponsor: Hanmi Pharmaceutical Company LimitedLast updated: 2025-12-17

Summary

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.

Arms & interventions

  • DrugHM16390

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

  • Drugpembrolizumab

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

Outcome measures

Primary

  • Incidence and nature of DLTs

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

    Time frame: 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.

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

    Time frame: Throughout the study until end of safety follow-up period (90 days after the last treatment)

Secondary

  • The maximum serum concentration (Cmax)

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

  • The time to reach Cmax (Tmax)

    Time frame: 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)

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

  • The AUC extrapolated to infinity (AUCinf)

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

  • The AUC during the dosing interval (AUCtau)

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

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

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

  • The elimination half-life (T1/2)

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

  • The apparent volume of distribution (Vd/F)

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

  • The apparent clearance (CL/F)

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

  • Objective response rate (ORR)

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

  • Disease Control Rate (DCR)

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

  • Progression-free survival (PFS)

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

  • Duration of response (DOR)

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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting

Karmanos Cancer Institute

Detroit, Michigan, 48201

Not Yet Recruiting