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Tests treatment safety and results for NSCLC
Official title Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer
ClinicalTrials.gov ID: NCT05877430
What this study is testing
What is CJRB-101?
CJRB-101 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for nsclc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- Diagnosis of locally advanced unresectable or metastatic NSCLC, HNSCC, or melanoma in people who are ICI treatment-naive or relapsed/refractory...
You likely can't join if
- Cancer type and genomic tumor aberrations:
- NSCLC people with EGFR or ALK genomic tumor aberrations
- HNSCC people with nasopharyngeal cancer
- For ICI refractory/relapsed people: Immune related AEs ≥Grade 3 that led to discontinuation of prior immune-modulatory agents including PD-1/PD-L1...
- With uncontrolled or untreated brain metastasis or leptomeningeal disease
- Active autoimmune disease that has required systemic treatment in the past 2 years
See the full eligibility criteria
Who can join
- 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
- Diagnosis of locally advanced unresectable or metastatic NSCLC, HNSCC, or melanoma in people who are ICI treatment-naive or relapsed/refractory, including PD-1/PD-L1 inhibitors
- ICI treatment-naive people must meet the following criteria:
- NSCLC: people with metastatic or with unresectable, recurrent NSCLC whose tumors must have no EGFR or ALK genomic aberrations and express PD-L1 [TPS≥50%]
- HNSCC: people with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [CPS ≥20]
- Melanoma: Irrespective of PD-L1 result and BRAF V600 mutation
- people has not received prior systemic treatment for their metastatic tumor. people who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months before...
- ICI treatment-refractory people as defined by the following criteria:
- Has received at least 2 cycles of anti-PD-(L)1 therapy either as monotherapy or in combination
- Has demonstrated disease progression after ICI treatment by RECIST v1.1
- Has received less than three lines of systemic therapy for metastatic tumor
- ECOG performance status of 0 or 1
- Be willing to provide archival tissue or fresh biopsy
- Have adequate organ function
- All Grade 3 or greater AEs resolved earlier to Grade 2 or less
What rules you out
- Cancer type and genomic tumor aberrations:
- NSCLC people with EGFR or ALK genomic tumor aberrations
- HNSCC people with nasopharyngeal cancer
- For ICI refractory/relapsed people: Immune related AEs ≥Grade 3 that led to discontinuation of prior immune-modulatory agents including PD-1/PD-L1 inhibitors
- With uncontrolled or untreated brain metastasis or leptomeningeal disease
- Active autoimmune disease that has required systemic treatment in the past 2 years
- Received a fecal transplant
- Concurrent participation in another treatment clinical study or use of another investigational agent within 30 days of study consent
- Contraindication to IV contrast that cannot be managed with pre-medication
- Female people who are pregnant or breastfeeding
- Male people who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy
- Has a known inability for oral intake of capsules
- Has received a live vaccine within 4 weeks of start of the study treatment
- Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy
- Has received whole blood transfusion, blood component transfusion, or colony stimulating factors within 1 week prior to the 1st dose of study treatment
- In the judgment of the investigator, people unlikely to comply with study procedures, restrictions and requirements
- Has active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids
- Have allergy to clindamycin, erythromycin, and ampicillin
- Has signs and symptoms of colitis at screening
- Infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before study treatment (Note: Antiviral therapy is permitted for people with chronic HBV or HCV infection)
- Untreated chronic hepatitis B or chronic HBV carriers with HBV DNA\>500 IU/mL (or \>2500 copies/mL) at screening (Note: Inactive hepatitis B surface antigen (HbsAg) carriers, treated and stable hepatitis B (HBV DNA \ 2...
- With active hepatitis C (Note: people with a negative HCV antibody test at screening or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening are eligible. The HCV RNA test will...
- Known history of HIV infection
- History of active inflammatory bowel disease with diarrhea believed to be caused by active inflammatory bowel disease in the past 12 months
- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of study informed consent and or if the subject has not fully recovered from the surgery within 4 weeks of informed consent
- History of major gastrointestinal surgery
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial
- Currently active, clinically significant cardiovascular disease
- Known active intravenous drug or alcohol abuse or use of other drugs of abuse
- Has any contraindication as mentioned in the recent Keytruda, Highlights of Prescribing Information (pembrolizumab)
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Pittsburgh, Pennsylvania, United States
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Pittsburgh, Pennsylvania, United States; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.