Study of CJRB-101 with Pembrolizumab for Advanced Cancers

This study is testing a new drug called CJRB-101 alongside an existing cancer treatment, pembrolizumab (a checkpoint inhibitor, which helps your immune system fight cancer), for people with advanced or metastatic (spread to other parts of the body) non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), or melanoma. Researchers want to see if this combination is safe, how well people tolerate it, and if it helps shrink tumors. You would receive CJRB-101 capsules daily and pembrolizumab injections every three weeks. The study is open to adults aged 18 and older who have measurable tumors. It's currently unclear if the study is actively enrolling participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatments you are receiving. It plans to enroll 160 participants across centers in the USA and Republic of Korea.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and how well the treatment works will be measured for a maximum of 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05877430

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
CJ Bioscience, Inc.
~160 participants
Updated 2024-12-20 on ClinicalTrials.gov
What's tested:CJRB-101Pembrolizumab injection

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
[Phase 1&2] Tolerability and Safety: Incidence of Adverse Events
Measured over Maximum 2 years
+1 more outcome measured
NSCLC
HNSCC
Melanoma
Metastatic Cancer
Advanced Solid Tumor
Advanced Cancer
4 sites across 3 states
South Korea2
California1
Pennsylvania1

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  • [Phase 1&2] Tolerability and Safety: Incidence of Adverse EventsMaximum 2 years

    Assessed per CTCAE v5.0

  • [Phase 2] EfficacyMaximum 2 years

    ORR