Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06234397
The ClinicalTrials.gov registry entry for NCT06234397 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 245 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 224-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target. 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.
NCT06234397 reports 10 study locations spanning 6 distinct geographic areas - top geographies include 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
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.
-
Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.