New treatment option for Lung Cancer, Non-small Cell
Official title A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
ClinicalTrials.gov ID: NCT06228326
What this study is testing
What is KB707?
KB707 is an investigational medicine, given as an once-weekly inhaled treatment, being studied as a potential treatment for lung cancer, non-small cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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
See the full eligibility 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...
- 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...
- 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...
- people 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. Key
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Dothan, Alabama, United States
- Scottsdale, Arizona, United States
- Beverly Hills, California, United States
- Redlands, California, United States
- Weston, Florida, United States
- Indianapolis, Indiana, United States
- New Orleans, Louisiana, United States
- Detroit, Michigan, United States
- Canton, Ohio, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Nasville, Tennessee, United States
- El Paso, Texas, United States
- The Woodlands, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dothan, Alabama, United States; Scottsdale, Arizona, United States; Beverly Hills, California, United States; Redlands, California, United States; Weston, Florida, United States; Indianapolis, Indiana, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.