OncoMatch/Clinical Trials/NCT05877430
Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer
Is NCT05877430 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including CJRB-101 and Pembrolizumab for nsclc.
Treatment: CJRB-101 · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Head and Neck Squamous Cell Carcinoma
Melanoma
Tumor Agnostic
Biomarker criteria
Required: EGFR genomic aberration (wild-type)
NSCLC: Subjects...must have no EGFR or ALK genomic aberrations
Required: ALK genomic aberration (wild-type)
NSCLC: Subjects...must have no EGFR or ALK genomic aberrations
Required: PD-L1 (CD274) overexpression (TPS ≥50%)
NSCLC: Subjects...express PD-L1 [TPS≥50%]
Required: PD-L1 (CD274) overexpression (CPS ≥20)
HNSCC: Subjects...express PD-L1 [CPS ≥20]
Disease stage
Metastatic disease required
Diagnosis of locally advanced unresectable or metastatic NSCLC, HNSCC, or melanoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
Kidney function
Liver function
Have adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, Irvine · Irvine, California
- University of Pittsburgh · Pittsburgh, Pennsylvania
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05877430 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require EGFR?
Yes, EGFR genomic aberration is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK genomic aberration is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 overexpression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify