Actively Recruiting
Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer
Led by CJ Bioscience, Inc. · Updated on 2024-12-20
160
Participants Needed
4
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent
- 18 years of age or older at the time of signing consent
- Pathologically confirmed diagnosis of NSCLC, HNSCC, or melanoma
- At least one measurable target lesion per RECIST v1.1 that has not been resected, biopsied, or irradiated before enrollment
- Diagnosis of locally advanced unresectable or metastatic NSCLC, HNSCC, or melanoma
- ICI treatment-naive subjects with specific tumor characteristics and no prior systemic treatment for metastatic tumor
- ICI treatment-refractory subjects who have received at least 2 cycles of anti-PD-(L)1 therapy and shown disease progression
- ECOG performance status of 0 or 1
- Willingness to provide archival tissue or fresh biopsy
- Adequate organ function
- All Grade 3 or greater adverse events resolved to Grade 2 or less
You will not qualify if you...
- NSCLC subjects with EGFR or ALK genomic tumor aberrations
- HNSCC subjects with nasopharyngeal cancer
- Immune-related adverse events Grade 3 or higher that led to discontinuation of prior immune-modulatory agents for ICI refractory/relapsed subjects
- Uncontrolled or untreated brain metastasis or leptomeningeal disease
- Active autoimmune disease requiring systemic treatment within the past 2 years
- Prior fecal transplant
- Participation in another interventional clinical study or use of investigational agent within 30 days of consent
- Contraindication to IV contrast not manageable with pre-medication
- Pregnant or breastfeeding females
- Males unwilling or unable to use acceptable birth control
- Inability to take capsules orally
- Receipt of live vaccine within 4 weeks before starting study treatment
- Immunodeficiency or organ transplant requiring immunosuppressive therapy
- Recent whole blood or blood component transfusion within 1 week before study treatment
- Unlikely to comply with study procedures
- Active or history of interstitial lung disease or pneumonitis requiring steroids
- Allergies to clindamycin, erythromycin, or ampicillin
- Signs or symptoms of colitis at screening
- Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before treatment
- Untreated chronic hepatitis B with high viral load at screening
- Active hepatitis C infection
- Known HIV infection
- Active inflammatory bowel disease with diarrhea in the past 12 months
- Major surgery within 4 weeks before consent or not fully recovered
- History of major gastrointestinal surgery
- Any condition, therapy, or lab abnormality confounding trial results
- Active, clinically significant cardiovascular disease
- Active intravenous drug or alcohol abuse
- Contraindications listed in pembrolizumab prescribing information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of California, Irvine
Irvine, California, United States, 92697
Actively Recruiting
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Actively Recruiting
3
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
4
Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
H
Hyun Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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