Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Se… (NCT05877430) | Clinical Trial Compass
RecruitingPhase 1/2
Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer
United States, South Korea160 participantsStarted 2023-09-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion 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
✓. Diagnosis of locally advanced unresectable or metastatic NSCLC, HNSCC, or melanoma in subjects who are ICI treatment-naive or relapsed/refractory, including PD-1/PD-L1 inhibitors
✓. ICI treatment-naive subjects must meet the following criteria:
✓. NSCLC: Subjects with metastatic or with unresectable, recurrent NSCLC whose tumors must have no EGFR or ALK genomic aberrations and express PD-L1 \[TPS≥50%\]
✓. HNSCC: Subjects with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 \[CPS ≥20\]
Exclusion criteria
What they're measuring
1
[Phase 1&2] Tolerability and Safety: Incidence of Adverse Events
✕. NSCLC subjects with EGFR or ALK genomic tumor aberrations
✕. HNSCC subjects with nasopharyngeal cancer
✕. For ICI refractory/relapsed subjects: 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 interventional clinical study or use of another investigational agent within 30 days of study consent