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

NCT06724016 · tracked via the Priya Life Science USA tracker

Sponsor

Hanmi Pharmaceutical Company Limited

Phase

Phase 1

Started

2024-12-11

Last updated

2026-11-03

Condition(s) studied

Advanced or Metastatic Solid Tumors

Investigational drug(s) / intervention(s)

HM16390pembrolizumab →

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Incidence and nature of DLTs — 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
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

Trial sites (8)

Facility	City	Region	Status
The Regents of the University of California on behalf of its Los Angeles campus	Los Angeles	California	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Karmanos Cancer Institute	Detroit	Michigan	Recruiting
Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Recruiting
Seoul National University Hospital	Seoul	South Korea	Recruiting
Severance Hospital	Seoul	South Korea	Recruiting
Asan Medical Center	Seoul	South Korea	Active Not Recruiting
Samsung Medical Center	Seoul	South Korea	Recruiting

On this site

📄 Keytruda (pembrolizumab) drug profile →

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Other trials for the same condition

A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors Active, not recruiting

Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors Active, not recruiting

A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors Recruiting

A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors Recruiting

To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06724016 on ClinicalTrials.gov ↗ ← All trials in the USA