RecruitingPhase 1Phase 2NCT05877430

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


Sponsor

CJ Bioscience, Inc.

Enrollment

160 participants

Start Date

Sep 11, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new treatment combination: CJRB-101 (a live bacterial product) plus pembrolizumab (an immunotherapy) in people with advanced lung cancer (NSCLC), head and neck cancer (HNSCC), or melanoma. CJRB-101 is designed to improve how well the immune system responds to immunotherapy. **You may be eligible if...** - You are 18 or older with confirmed NSCLC, HNSCC, or melanoma that has spread or cannot be removed by surgery - For newly diagnosed patients: NSCLC tumors must have no EGFR/ALK mutations and have high PD-L1 expression; HNSCC must have high PD-L1; melanoma patients qualify regardless of PD-L1 - For previously treated patients: You have had at least 2 cycles of a checkpoint inhibitor and your cancer has progressed, and you have had fewer than 3 prior lines of treatment - Your health status is good (ECOG 0–1) **You may NOT be eligible if...** - You have active autoimmune disease, HIV, hepatitis B or C, or inflammatory bowel disease - You have received a fecal transplant - You are pregnant or breastfeeding - You have active lung inflammation (ILD/pneumonitis) - You are allergic to clindamycin, erythromycin, or ampicillin - You have untreated brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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, Irvine

Irvine, California, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Samsung Medical Center

Seoul, South Korea

Severance Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05877430


Related Trials