Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Hanmi Pharmaceutical Company Limited.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate safety and tolerability of HM16390 as a single agent and in combination with pembrolizumab
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 |
What NCT06724016 shows while recruiting
NCT06724016 is an interventional study that assigns participants to a tested intervention. The registered 292 participants enrollment target is mid-sized for trials with a published cap, above the 222-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (32% higher).
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 lists 7 locations in 4 states (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.
Learn More About Clinical Trials
Similar trials for Advanced or Metastatic Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06724016's enrollment target sits among peer trials
292 3rd of 19 higher than 17 of 19 other Advanced or Metastatic Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced or Metastatic Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Phase 1 Study of LNCB74 in Advanced Solid Tumors
RECRUITING · Phase 1
-
To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04429542 · 292 participants · Phase 1
Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
- NCT05406622 · 292 participants · NA
MOTIV BTK Randomized Controlled Trial
- NCT05757102 · 292 participants · Phase 3
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
- NCT06569667 · 292 participants · NA
Using AI and Peer Coaching to Address Racial Disparities Among People Who Use Opioids
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI