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

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.

Timeline

Start

2023-09-11

Primary completion

2026-07

Completion

2027-10

Publications

• Lee JB, Baek S, Kim DK, Kwon BE, Ahn JS, Nagasaka M, Davar D, Park H, Kim H, Im J, Yang J, Yang E, Shin GH, Choi S, Kwon JE, Kim JM, Kang SY, Kim Y, Park SY, Kim JH, Oh HS, Chalita M, Min A, Cho BC. Phase I trial of CJRB-101 plus pembrolizumab in patients with metastatic non-small cell lung cancer, head and neck squamous cell carcinoma and melanoma. J Immunother Cancer. 2026 May 15;14(5):e014702. doi: 10.1136/jitc-2025-014702.

Drugs

Indications