A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs

ClinicalTrials.gov ID: NCT06228326

Public ClinicalTrials.gov record NCT06228326. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 3, 2026, 11:33 PM EDT

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Official title

KB707-02: A Phase 1/2 Study of Inhaled KB707 in Patients With Advanced Solid Tumor Malignancies Affecting the Lungs

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06228326
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Krystal Biotech, Inc.; Industry
Enrollment: 250 participants

Conditions and interventions

Conditions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 16, 2024
Primary completion: Jan 31, 2027
Completion: Jun 30, 2028
Last update posted: Oct 23, 2025

2024 – 2028

United States locations

U.S. sites: 14
U.S. states: 11
U.S. cities: 14

Facility	City	State	ZIP	Site status
XCancer Research Network/Dothan Hematology & Oncology	Dothan	Alabama	36303	Recruiting
HonorHealth Research Institute	Scottsdale	Arizona	85258	Recruiting
Precision NextGen Oncology	Beverly Hills	California	90212	Recruiting
Emad Ibrahim MD Inc	Redlands	California	92373	Recruiting
BRCR Global	Weston	Florida	33326	Recruiting
IU Simon Comprehensive Cancer Center	Indianapolis	Indiana	46202	Terminated
Ochsner/MD Anderson Cancer Center	New Orleans	Louisiana	70121	Recruiting
Henry Ford Health	Detroit	Michigan	48202	Recruiting
Gabrail Cancer Center Research	Canton	Ohio	44718	Recruiting
Cleveland Clinic	Cleveland	Ohio	44195	Recruiting
UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	15232	Terminated
Sarah Cannon Research Institute	Nasville	Tennessee	37203	Recruiting
Renovatio Clinical	El Paso	Texas	79915	Terminated
Renovatio Clinical	The Woodlands	Texas	77380	Terminated

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06228326, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 23, 2025 · Synced Sep 3, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06228326 live on ClinicalTrials.gov.

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