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Study identifier: NCT06724016 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Advanced or Metastatic Solid Tumors  ·  Sponsor: Hanmi Pharmaceutical Company Limited

PhasePhase 1
Planned participants292
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Young Su (Bobby) Noh  ·  82-2-410-9277  ·  63forever@hanmi.co.kr

Always discuss trial participation with your own doctor first.

Locations (7)

Massachusetts General HospitalBoston, Massachusetts, United StatesRecruiting
Karmanos Cancer InstituteDetroit, Michigan, United StatesNot Yet Recruiting
Seoul National University Bundang HospitalSeongnam-si, Gyeonggi-do, South KoreaRecruiting
Seoul National University HospitalSeoul, South KoreaRecruiting
Severance HospitalSeoul, South KoreaRecruiting
Asan Medical CenterSeoul, South KoreaActive Not Recruiting
Samsung Medical CenterSeoul, South KoreaRecruiting

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Source record: clinicaltrials.gov/study/NCT06724016