NCT05877430

Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: CJ Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC
• HNSCC
• Melanoma
• Metastatic Cancer
• Advanced Solid Tumor
• Advanced Cancer

Interventions

Type	Name	Description
DRUG	CJRB-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.
DRUG	Pembrolizumab injection	200 mg given by intravenous (IV) infusion once every 3 weeks

Timeline

• Start date: 2023-09-11
• Primary completion: 2026-07-01
• Completion: 2027-10-01
• First posted: 2023-05-26
• Last updated: 2024-12-20

Locations

4 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study