CJ Bioscience, Inc.
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.
NSCLC
HNSCC
Melanoma
Metastatic Cancer
Advanced Solid Tumor
Advanced Cancer
CJRB-101
Pembrolizumab injection
Phase 1
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 160 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | September 11, 2023 |
Estimated Primary Completion Date : | July 2026 |
Estimated Study Completion Date : | October 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: CJRB-101 with pembrolizumab Phase 1 includes patients with selected types of advanced or metastatic cancers. Patients will be given with either low or high dose levels of CJRB-101 in combination with pembrolizumab. Phase 2 includes patients with selected types of advanced or metastatic cancers. Patients will be given with the CJRB-101 dose selected from Phase 1 in combination with pembrolizumab. |
Drug: CJRB-101 Drug: Pembrolizumab injection |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
CJ bioscience investigative site
Seoul, Korea, Republic of,