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NCT05877430 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer
A Phase 1 study of Melanoma and Advanced Solid Tumor, sponsored by CJ Bioscience.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 160
- Enrollment target
- 4
- Study locations
NCT05877430 is a Phase 1 study of Melanoma and Advanced Solid Tumor that is actively recruiting participants, run by CJ Bioscience. The registered enrollment target is 160 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (77% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT05877430, a Phase 1 study of Melanoma and Advanced Solid Tumor, is actively recruiting participants, sponsored by CJ Bioscience.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 160 participants
- Enrollment target
- 4
- Study locations
Study Summary
Study CJB-101-01 will be conducted at multiple centers in the USA and Republic of Korea as an open-label safety and preliminary efficacy study of CJRB-101 in combination with pembrolizumab in subjects with selected types of advanced or metastatic cancer. The proposed study intends to address the unmet medical needs of low response rate and refractoriness to immune checkpoint inhibitors typically observed in this subject population by performing assessments of response, dose limiting toxicities, pharmacodynamic, and the effect on microbiome biomarkers at different dose levels of CJRB-101 combined with pembrolizumab.
Conditions Studied
Interventions
- DRUG Pembrolizumab injection
- DRUG CJRB-101
Study Locations (4)
Other
- Samsung Medical Center - Seoul
- Severance Hospital - Seoul
California
- University of California, Irvine - Irvine
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2023-09-11 |
| Est. Completion | 2027-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05877430
The ClinicalTrials.gov registry entry for NCT05877430 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (77% lower). The listed sponsor is CJ Bioscience, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab injection is the first listed.
NCT05877430 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Other, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05877430 about?
NCT05877430 is a clinical study titled "Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer". Study CJB-101-01 will be conducted at multiple centers in the USA and Republic of Korea as an open-label safety and preliminary efficacy study of CJRB-101 in combination with pembrolizumab in subjects with selected types of advanced or metastatic cancer. The proposed study intends to address the unm...
What is the current status of trial NCT05877430?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2023-09-11. Estimated completion is 2027-10.
What conditions does trial NCT05877430 study?
This clinical trial studies the following conditions: Melanoma, Advanced Solid Tumor, Advanced Cancer, Metastatic Cancer, NSCLC.
What interventions are being tested in trial NCT05877430?
The interventions under investigation include: Pembrolizumab injection (DRUG), CJRB-101 (DRUG).
Who is sponsoring clinical trial NCT05877430?
This trial is sponsored by CJ Bioscience, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05877430 being conducted?
This trial has 4 study locations across California, Pennsylvania. 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
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.