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

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 combin

Trial Details

NCT ID

NCT05877430

Phase

PHASE1 / PHASE2

Sponsor

CJ Bioscience, Inc.

Status

RECRUITING

Cancer Type

Head and Neck Cancer

Interventions

CJRB-101
Pembrolizumab injection

Locations (sample)

Irvine, California, United States|33.66946,-117.82311
Pittsburgh, Pennsylvania, United States|40.44062,-79.99589
Seoul, South Korea|37.566,126.9784
Seoul, South Korea|37.566,126.9784

Key Eligibility Criteria

Willing and able to provide informed consent
≥18 years of age at the time of signing the informed consent form
Pathologically documented histological or cytological evidence of NSCLC, HNSCC, or melanoma.
Has at least 1 measurable target lesion per RECIST v1.1 that has not been resected/biopsied/or irradiated before enrollment in the study

For full eligibility, visit ClinicalTrials.gov.

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