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
CJ Bioscience, Inc.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Willing and able to provide informed consent 2. ≥18 years of age at the time of signing the informed consent form 3. Pathologically documented histological or cytological evidence of NSCLC, HNSCC, or melanoma. 4. Has at least 1 measurable target lesion per RECIST v1.1 that has not been resected/biopsied/or irradiated before enrollment in the study 5. Diagnosis of locally advanced unresectable or metastatic NSCLC, HNSCC, or melanoma in subjects who are ICI treatment-naive or relapsed/refractory, including PD-1/PD-L1 inhibitors 6. ICI treatment-naive subjects must meet th…
Interventions
- DrugCJRB-101
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.
- DrugPembrolizumab injection
200 mg given by intravenous (IV) infusion once every 3 weeks
Locations (4)
- University of California, IrvineIrvine, California
- University of PittsburghPittsburgh, Pennsylvania
- Samsung Medical CenterSeoul
- Severance HospitalSeoul