Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06724016 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study title shortened, about 3 wordsv4
  2. Primary and study completion dates: Mar 2030 to Jul 2031v3 Show 8 more changesShow less
    • Enrollment target: 215 to 292
    • Study sites: 3 to 7
    • Interventions: HM16390 (Drug) to HM16390 (Drug), pembrolizumab (Drug)
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 2 of 13 entries
    • Study title expanded, about 7 words
    • Study arms: 1 to 2
    • Collaborators expanded, about 5 words
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 2024 to Dec 11, 2024
    • Site details revised at 3 of 3 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06724016
Lead Sponsor Hanmi Pharmaceutical Company Limited
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Advanced or Metastatic Solid Tumors
Enrollment 292 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov