A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
KYANITE-1
KB707-02: A Phase 1/2 Study of Inhaled KB707 in Patients With Advanced Solid Tumor Malignancies Affecting the Lungs
1 other identifier
interventional
250
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2024
Longer than P75 for phase_1
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2024
CompletedFirst Posted
Study publicly available on registry
January 29, 2024
CompletedStudy Start
First participant enrolled
April 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
October 24, 2025
October 1, 2025
2.8 years
January 18, 2024
October 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and tolerability of inhaled KB707 based upon assessment of adverse events (AE)
Percentage of subjects with treatment-related AEs as assessed by NCI-CTCAE v5
up to 36 months
Secondary Outcomes (2)
To evaluate whether the proposed dose ranges include the maximum tolerated dose of KB707 as determined by incidence of dose limiting toxicities (DLTs)
up to 36 months
To evaluate the preliminary efficacy of inhaled KB707 as determined by overall response rate (ORR)
up to 36 months
Study Arms (4)
Cohorts 1 through 4
EXPERIMENTALDose escalation and expansion cohorts: KB707 monotherapy in subjects with solid tumor malignancies affecting the lungs.
Cohort 5
EXPERIMENTALDose expansion cohort: KB707 administered in combination with Keytruda in approximately 60 subjects with NSCLC.
Cohort 6
EXPERIMENTALDose expansion cohort: KB707 administered in combination with Keytruda and chemotherapy in approximately 60 subjects with NSCLC.
Experimental: Cohort 7
EXPERIMENTALDose expansion cohort: KB707 administered in combination with docetaxel in approximately 50 subjects with NSCLC.
Interventions
Genetically modified herpes simplex type 1 virus
Eligibility Criteria
You may qualify if:
- Age 18 years or older at the time of informed consent
- Life expectancy \>12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have at least one measurable lung lesion per RECIST v1.1 at Screening
- Cohorts 1 through 4 only: Histologically confirmed diagnosis of advanced solid tumor malignancy affecting the lungs and the individual has progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or has no standard of care therapy.
- Cohorts 5, 6, and 7 only: (1) Histologically or cytologically confirmed diagnosis of stage 3 or 4 NSCLC, as per American Joint Committee on Cancer (AJCC) staging system (8th edition) and (2) Subject must meet the following criteria of prior lines of therapy:
- Subject has previously received no more than one line of prior immune checkpoint inhibitor (ICI) with or without platinum-based chemotherapy, or no more than two prior lines of therapy when given the ICI and platinum-based chemotherapy sequentially as two separate lines.
- Subjects with an actionable mutation (e.g., EGFR, KRAS, ALK, or ROS1 genomic alteration), are permitted to have received one additional line of approved targeted therapy.
You may not qualify if:
- Not fully recovered from prior surgery or radiotherapy, including all radiation-related toxicities
- The subject is pregnant, nursing, or plans to become pregnant during study treatment and through three months after the last dose of KB707
- Have known history of positive human immunodeficiency virus (HIV 1/2)
- Cohorts 5, 6, and 7 only:
- Subject has a known additional malignancy that is progressing or requires active treatment
- Subject has active brain metastases or leptomeningeal metastases
- Prior anti-PD-1/PD-L1 therapy was intolerable and required discontinuation of treatment
- Subject has active, known, or suspected autoimmune disease requiring systemic treatment
- Subject has known acute or chronic hepatitis
- Subject has active pneumonitis or history of ICI-induced pneumonitis that required steroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David Chien, MD
Senior Vice President of Clinical Development
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2024
First Posted
January 29, 2024
Study Start
April 17, 2024
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
October 24, 2025
Record last verified: 2025-10