NCT06228326 · Krystal Biotech, Inc.
A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
What this study is about
The Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector that is designed to stimulate an anti-tumor immune response through the production of cytokines delivered to the airways of people with advanced solid tumor malignancies affecting the lungs via nebulization.
View original scientific description
The Sponsor is developing KB707, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector that is designed to stimulate an anti-tumor immune response through the production of cytokines delivered to the airways of people with advanced solid tumor malignancies affecting the lungs via nebulization.
Interventions
BIOLOGICAL
KB707
Genetically modified herpes simplex type 1 virus
DRUG
Pembrolizumab (KEYTRUDA®)
PD-1 immune checkpoint inhibitor
DRUG
Chemotherapy
SOC chemotherapy
DRUG
Docetaxel
SOC chemotherapy
Primary outcome measures
To evaluate the safety and tolerability of inhaled KB707 based upon assessment of adverse events (AE)
Time frame: up to 36 months
Percentage of subjects with treatment-related AEs as assessed by NCI-CTCAE v5
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 and 6 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: 1. 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
Where
- Dothan, Alabama
- Scottsdale, Arizona
- Beverly Hills, California
- Redlands, California
- Weston, Florida
- Indianapolis, Indiana
- New Orleans, Louisiana
- Detroit, Michigan
- Canton, Ohio
- Cleveland, Ohio
- Pittsburgh, Pennsylvania
- Nasville, Tennessee
And 2 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 24, 2025 · Source of record for eligibility and locations