Recruiting
Phase 1

HM16390 & Pembrolizumab

Sponsor:

Hanmi Pharmaceutical Company Limited

Code:

NCT06724016

Conditions

Advanced or Metastatic Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HM16390

pembrolizumab

Study Details

Brief 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.

Conditions

Advanced or Metastatic Solid Tumors

Study ID

NCT06724016

Start date

Dec 11, 2024

Status verified date

Dec, 2025

Completion date

Jul, 2031

Anticipated

Primary completion date

Jul, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

292 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HM16390

HM16390 Monotherapy

experimental: HM16390 + pembrolizumab

HM16390 in combination with pembrolizumab

Interventions

HM16390

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

pembrolizumab

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

Primary outcome measure

  • Incidence and nature of DLTs [ 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. [ Time Frame: Throughout the study until end of safety follow-up period (90 days after the last treatment) ]

Central Contacts and Locations

Central contacts

Young Su (Bobby) Noh

82-2-410-927763forever@hanmi.co.kr

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Hanmi Pharmaceutical Company Limited

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hanmi Pharmaceutical Company Limited on 2025-12-17.