Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors
NCT ID: NCT06724016
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
292 participants
INTERVENTIONAL
2024-12-11
2031-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
2. Dose-Ranging Part: Subjects will be randomized 1:1 into at least two dose levels to enable better selection of the doses for further evaluation, and may apply to cohorts of both monotherapy and combination therapy
3. Dose-Expansion Part: Based on the available data from Dose-Escalation and Dose-Ranging parts, the most feasible dose will be selected as the RDE and will be administered to subjects in indication-specific expansion cohorts
TREATMENT
NONE
Study Groups
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HM16390
HM16390 Monotherapy
HM16390
HM16390 will be administered subcutaneously using syringes on Day 1 of every 3-week treatment cycle
HM16390 + pembrolizumab
HM16390 in combination with pembrolizumab
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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KEYNOTE-G39
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-G39
Identifier Type: OTHER
Identifier Source: secondary_id
HM-LIL2-101
Identifier Type: -
Identifier Source: org_study_id