At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed NSCLC, HNSCC, or melanoma
- ✓Locally advanced unresectable or metastatic disease
- ✓At least 1 measurable target lesion per RECIST v1.1 not previously resected/biopsied/irradiated
- ✓ICI-naive subjects: NSCLC with no EGFR/ALK mutations and PD-L1 TPS≥50%
- ✕NSCLC with EGFR or ALK genomic aberrations
- ✕HNSCC with nasopharyngeal cancer
- ✕ICI-refractory subjects with immune-related AEs ≥Grade 3 leading to prior ICI discontinuation
- ✕Uncontrolled or untreated brain metastasis or leptomeningeal disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1/2 Open Label, Safety and Preliminary Efficacy Study of a Live Biotherapeutic Product (CJRB-101) in Combination With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer
In Brief
A Phase 2 clinical trial evaluating CJRB-101 and Pembrolizumab injection for NSCLC and 5 related conditions. Currently recruiting, targeting 160 participants across 4 sites in 2 countries.
Signals
Detailed 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.
Study Details
Timeline
Interventions
In Phase 1, one or two capsules of CJRB-101 will be given every day. In Phase 2, the CJRB-101 dose selected from Phase 1 will be given every day.
200 mg given by intravenous (IV) infusion once every 3 weeks