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A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
NCT06228326 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Chemotherapy
- BIOLOGICAL KB707
- DRUG Pembrolizumab (KEYTRUDA®)
Study Locations (14)
California
- Precision NextGen Oncology — Beverly Hills
- Emad Ibrahim MD Inc — Redlands
Ohio
- Gabrail Cancer Center Research — Canton
- Cleveland Clinic — Cleveland
Texas
- Renovatio Clinical — El Paso
- Renovatio Clinical — The Woodlands
Alabama
- XCancer Research Network/Dothan Hematology & Oncology — Dothan
Arizona
- HonorHealth Research Institute — Scottsdale
Florida
- BRCR Global — Weston
Indiana
- IU Simon Comprehensive Cancer Center — Indianapolis
Louisiana
- Ochsner/MD Anderson Cancer Center — New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-04-17 |
| Est. Completion | 2028-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06228326
The ClinicalTrials.gov registry entry for NCT06228326 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Krystal Biotech, which has 66 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Advanced Cancer appearing as the primary indexed condition, and to 4 interventions — of which Docetaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06228326 reports 14 study locations spanning 11 distinct geographic areas — top geographies include California, Ohio, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06228326 about?
NCT06228326 is a clinical study titled "A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs". 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 nebuliz...
What is the current status of trial NCT06228326?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 250 participants. The study started on 2024-04-17. Estimated completion is 2028-07.
What conditions does trial NCT06228326 study?
This clinical trial studies the following conditions: Advanced Cancer, Solid Tumor, Adult, Lung Cancer Metastatic, Lung Cancer (NSCLC), Lung Cancer, Non-small Cell. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06228326?
The interventions under investigation include: Docetaxel (DRUG), Chemotherapy (DRUG), KB707 (BIOLOGICAL), Pembrolizumab (KEYTRUDA®) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06228326?
This trial is sponsored by Krystal Biotech, which has 66 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06228326 being conducted?
This trial has 14 study locations across Alabama, Arizona, California, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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