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NCT06234397 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb 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
- 245
- Enrollment target
- 10
- Study locations
NCT06234397: Recruiting Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Hanmi Pharmaceutical Company Limited.
NCT06234397 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 245 participants, roughly in line with the 224-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target. The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06234397, 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
- 245 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, 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 RD for Dose-Expansion part, while Dose-Expansion part is designed to assess potential efficacy of BH3120, as a single agent and in combination with pembrolizumab, when administered at the RD to subjects in indication-specific expansion cohorts.
Primary Outcome
To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration
Conditions Studied
Interventions
- DRUG pembrolizumab
- DRUG BH3120
Study Locations (10)
Other
- Seoul National University Hospital - Seoul
- Severance Hospital - Seoul
- Asan Medical Center - Seoul
- Samsung Medical Center - Seoul
Texas
- Mary Crowley Cancer Research - Dallas
- Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center - San Antonio
Florida
- Moffitt Cancer Center - Tampa
Michigan
- The START Center for Cancer Care - Midwest - Grand Rapids
Ohio
- Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center - Cincinnati
Gyeonggi-do
- Seoul National University Bundang Hospital - Seongnam-si
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2023-12-28 |
| Est. Completion | 2028-01 |
| Phase | Phase 1 |
What NCT06234397 shows while recruiting
NCT06234397 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 224-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target.
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.
NCT06234397 lists 10 locations in 6 states (Other, Texas, Florida).
Frequently Asked Questions
What is clinical trial NCT06234397 about?
NCT06234397 is a clinical study titled "Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors". This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, 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 establi...
What is the current status of trial NCT06234397?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 245 participants. The study started on 2023-12-28. Estimated completion is 2028-01.
What conditions does trial NCT06234397 study?
This clinical trial studies the following conditions: Advanced or Metastatic Solid Tumors.
What interventions are being tested in trial NCT06234397?
The interventions under investigation include: pembrolizumab (DRUG), BH3120 (DRUG).
Who is sponsoring clinical trial NCT06234397?
This trial is sponsored by Hanmi Pharmaceutical Company Limited, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06234397 being conducted?
This trial has 10 study locations across Florida, Michigan, Ohio, Texas, Gyeonggi-do. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06234397's enrollment target sits among peer trials
245 6th of 19 higher than 14 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.
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