Actively Recruiting
Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors
Led by Hanmi Pharmaceutical Company Limited · Updated on 2025-12-17
292
Participants Needed
7
Research Sites
341 weeks
Total Duration
On this page
Sponsors
H
Hanmi Pharmaceutical Company Limited
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older (or legal age of majority if higher)
- Histologically or cytologically confirmed advanced or metastatic solid tumor
- Failed or intolerant to standard therapy with clinical benefit
- Measurable or evaluable disease at baseline (per RECIST v1.1 criteria by CT or MRI)
- ECOG performance status of 0 or 1 within 7 days before randomization
- Adequate kidney function
- Adequate blood (hematologic) function
- Adequate liver function
You will not qualify if you...
- Prior treatment with agents targeting IL-2, IL-7, or IL-15 receptors or related to HM16390's action
- Known active central nervous system metastases or carcinomatous meningitis
- History of severe toxicities from prior immunotherapy
- Unresolved or clinically significant treatment-related toxicities exceeding Grade 1 per NCI-CTCAE v5.0
- Ongoing or suspected autoimmune disease
- Active and significant bacterial, fungal, or viral infections including HIV/AIDS
- History of chronic liver disease or liver cirrhosis
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Not Yet Recruiting
3
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
4
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
5
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
6
Asan Medical Center
Seoul, South Korea, 05505
Active, Not Recruiting
7
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
Y
Young Su (Bobby) Noh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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