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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: Recruiting Phase 1 study of Melanoma and Advanced Solid Tumor, sponsored by CJ Bioscience.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessed per CTCAE v5.0
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 |
What NCT05877430 shows while recruiting
NCT05877430 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (77% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Melanoma
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 NCT05877430's enrollment target sits among peer trials
160 84th of 266 higher than 183 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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
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