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NCT06724016 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors
A Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Hanmi Pharmaceutical Company Limited.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 292
- Enrollment target
- 7
- Study locations
NCT06724016 is a Phase 1 study of Advanced or Metastatic Solid Tumors that is actively recruiting participants, run by Hanmi Pharmaceutical Company Limited. The registered enrollment target is 292 participants, above the 222-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (32% higher). The trial reports 7 study locations across 4 states.
The verdict
NCT06724016, a Phase 1 study of Advanced or Metastatic Solid Tumors, is actively recruiting participants, sponsored by Hanmi Pharmaceutical Company Limited.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 292 participants
- Enrollment target
- 7
- Study locations
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.
Conditions Studied
Interventions
- DRUG pembrolizumab
- DRUG HM16390
Study Locations (7)
Other
- Seoul National University Hospital - Seoul
- Severance Hospital - Seoul
- Asan Medical Center - Seoul
- Samsung Medical Center - Seoul
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Karmanos Cancer Institute - Detroit
Gyeonggi-do
- Seoul National University Bundang Hospital - Seongnam-si
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2024-12-11 |
| Est. Completion | 2031-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06724016
The ClinicalTrials.gov registry entry for NCT06724016 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 292 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 222-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (32% higher). The listed sponsor is Hanmi Pharmaceutical Company Limited, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Advanced or Metastatic Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which pembrolizumab is the first listed.
NCT06724016 reports 7 study locations spanning 4 distinct geographic areas - top geographies include Other, Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT06724016 about?
NCT06724016 is a clinical study titled "Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors". 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 establ...
What is the current status of trial NCT06724016?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 292 participants. The study started on 2024-12-11. Estimated completion is 2031-07.
What conditions does trial NCT06724016 study?
This clinical trial studies the following conditions: Advanced or Metastatic Solid Tumors.
What interventions are being tested in trial NCT06724016?
The interventions under investigation include: pembrolizumab (DRUG), HM16390 (DRUG).
Who is sponsoring clinical trial NCT06724016?
This trial is sponsored by Hanmi Pharmaceutical Company Limited, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06724016 being conducted?
This trial has 7 study locations across Massachusetts, Michigan, Gyeonggi-do. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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