Condition: Lung Cancer, Non-small Cell · Lung Cancer Metastatic · Solid Tumor, Adult · Sponsor: Krystal Biotech, Inc.
The Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector designed to stimulate an anti-tumor immune response through the production of cytokines within the local tumor microenvironment in the lungs. KB707 is administered via nebulization, delivering the therapy directly through the airways to the lungs of subjects with advanced solid tumor malignancies. This is a Phase 1/2, open-label, multicenter, dose escalation and expansion study designed to evaluate the safety, tolerability, preliminary efficacy, and immunologic effect of KB707. Monotherapy KB707 dose escalation and expansion cohorts enrolled adults with advanced solid tumor malignancies affecting the lungs who had progressed on standard of care therapy, cannot tolerate standard of care therapy, or refused standard of care therapy. The dose escalation phase (Cohorts 1 and 2) evaluated KB707 monotherapy using a standard 3+3 design, followed by a dose expansion phase (Cohort 4) to further evaluate the selected dose. Subjects received inhaled KB707 weekly for three weeks, then every three weeks. The dose escalation portion of the study is now complete, and the selected dose is being evaluated in the expansion phase. Combination regimens with a selected (fixed) dose of KB707 are being evaluated in subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Subjects in Cohorts 5 and 6 are receiving inhaled KB707 once every 2 weeks (q2w), deliv…
This description comes directly from the study's public registry record.
David Chien, MD · 412-586-5830 · dchien@krystalbio.com
Brittani Agostini, RN, CCRC · 412-586-5830 · bagostini@krystalbio.com
Always discuss trial participation with your own doctor first.
| XCancer Research Network/Dothan Hematology & Oncology | Dothan, Alabama, United States | Recruiting |
| HonorHealth Research Institute | Scottsdale, Arizona, United States | Recruiting |
| Precision NextGen Oncology | Beverly Hills, California, United States | Recruiting |
| Emad Ibrahim MD Inc | Redlands, California, United States | Recruiting |
| BRCR Global | Weston, Florida, United States | Recruiting |
| IU Simon Comprehensive Cancer Center | Indianapolis, Indiana, United States | Terminated |
| Ochsner/MD Anderson Cancer Center | New Orleans, Louisiana, United States | Recruiting |
| Henry Ford Health | Detroit, Michigan, United States | Recruiting |
| Gabrail Cancer Center Research | Canton, Ohio, United States | Recruiting |
| Cleveland Clinic | Cleveland, Ohio, United States | Recruiting |
| UPMC Hillman Cancer Center | Pittsburgh, Pennsylvania, United States | Terminated |
| Sarah Cannon Research Institute | Nasville, Tennessee, United States | Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06228326