A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
Start Date
4/17/2024
Completion Date
7/1/2028
Summary
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), delivered in combination with Keytruda once every 6 weeks. Subjects in Cohort 7 are receiving inhaled KB707 in combination with docetaxel once every 3 weeks. All subjects will be treated until tumor progression, death, unacceptable toxicity, symptomatic deterioration, achievement of maximal response, subject choice, Investigator decision to discontinue treatment, or the Sponsor determines to terminate the study.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
KB707
Pembrolizumab (KEYTRUDA®)
Chemotherapy
Docetaxel
Conditions
Locations
XCancer Research Network/Dothan Hematology & Oncology
Dothan, Alabama 36303
United States
HonorHealth Research Institute
Scottsdale, Arizona 85258
United States
Precision NextGen Oncology
Beverly Hills, California 90212
United States
Emad Ibrahim MD Inc
Redlands, California 92373
United States
BRCR Global
Weston, Florida 33326
United States
IU Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202
United States
Ochsner/MD Anderson Cancer Center
New Orleans, Louisiana 70121
United States
Henry Ford Health
Detroit, Michigan 48202
United States
Gabrail Cancer Center Research
Canton, Ohio 44718
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Sarah Cannon Research Institute
Nasville, Tennessee 37203
United States
Renovatio Clinical
El Paso, Texas 79915
United States
Renovatio Clinical
The Woodlands, Texas 77380
United States