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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.

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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.

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

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

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