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RECRUITING Phase 1

Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer

NCT05877430 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 160 participants
Start Date 2023-09-11
Est. Completion 2027-10
Phase Phase 1

Sponsor

CJ Bioscience

1 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CJ Bioscience, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05877430 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Other, California, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05877430?

The interventions under investigation include: Pembrolizumab injection (DRUG), CJRB-101 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05877430?

This trial is sponsored by CJ Bioscience, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial