Actively Recruiting
KB707-02: Phase 1/2 Trial of Inhaled KB707 Alone or with Keytruda and Chemotherapy for Advanced Solid Tumors in the Lungs
Led by Krystal Biotech, Inc. · Updated on 2025-10-24
250
Participants Needed
14
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying KB707, a genetically modified herpes simplex virus type 1 (HSV-1) vector designed to trigger an immune response against tumors in the lungs. This Phase 1/2 open-label trial evaluates the safety, tolerability, early effectiveness, and immune effects of KB707 in adults with advanced solid tumors affecting the lungs, including non-small cell lung cancer (NSCLC). The study focuses on patients who have progressed on or cannot tolerate standard treatments or have refused them. Participants receive KB707 inhaled through nebulization, delivering the therapy directly to the lungs. The study has multiple parts: dose escalation and expansion cohorts using KB707 alone, and additional cohorts combining KB707 with Keytruda (an immune checkpoint inhibitor) or chemotherapy drugs, such as docetaxel. Treatment schedules vary by cohort, with KB707 given weekly or every two to three weeks alongside other therapies, continuing until tumor progression or other specified reasons for stopping. During the study, participants undergo assessments to monitor safety and side effects, including tracking adverse events for up to 36 months. Researchers also evaluate tumor response and immune activity. Treatment continues as long as it is tolerated and beneficial, with regular evaluations to measure overall response and detect dose-related toxicities. The study is ongoing through July 2028, with participants receiving close monitoring throughout.
CONDITIONS
Brief Title
A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Life expectancy greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable lung lesion per RECIST v1.1 at screening
- For Cohorts 1-4: Histologically confirmed advanced solid tumor malignancy affecting the lungs with progression on, intolerance to, refusal of, or no standard of care therapy
- For Cohorts 5-7: Histologically or cytologically confirmed stage 3 or 4 non-small cell lung cancer (NSCLC)
- For Cohorts 5-7: No more than one prior immune checkpoint inhibitor line with or without platinum-based chemotherapy, or no more than two prior lines if given sequentially
- For subjects with actionable mutations, one additional line of approved targeted therapy is allowed
You will not qualify if you...
- Not fully recovered from prior surgery or radiotherapy, including radiation-related toxicities
- Pregnant, nursing, or planning to become pregnant during treatment and for three months afterward
- Known history of positive HIV 1/2
- For Cohorts 5-7: Having a progressing additional malignancy needing active treatment
- For Cohorts 5-7: Active brain or leptomeningeal metastases
- For Cohorts 5-7: Prior intolerance to anti-PD-1/PD-L1 therapy requiring discontinuation
- For Cohorts 5-7: Active, known, or suspected autoimmune disease requiring systemic treatment
- For Cohorts 5-7: Known acute or chronic hepatitis
- For Cohorts 5-7: Active pneumonitis or history of immune checkpoint inhibitor-induced pneumonitis requiring steroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 36 months
Participants receive inhaled KB707 alone or in combination with Keytruda, chemotherapy, or docetaxel as part of dose escalation and expansion cohorts for advanced solid tumors affecting the lungs.
Trial Site Locations
Total: 14 locations
1
XCancer Research Network/Dothan Hematology & Oncology
Dothan, Alabama, United States, 36303
Actively Recruiting
2
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
Precision NextGen Oncology
Beverly Hills, California, United States, 90212
Actively Recruiting
4
Emad Ibrahim MD Inc
Redlands, California, United States, 92373
Actively Recruiting
5
BRCR Global
Weston, Florida, United States, 33326
Actively Recruiting
6
IU Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Terminated
7
Ochsner/MD Anderson Cancer Center
New Orleans, Louisiana, United States, 70121
Actively Recruiting
8
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
9
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Actively Recruiting
10
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
11
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Terminated
12
Sarah Cannon Research Institute
Nasville, Tennessee, United States, 37203
Actively Recruiting
13
Renovatio Clinical
El Paso, Texas, United States, 79915
Terminated
14
Renovatio Clinical
The Woodlands, Texas, United States, 77380
Terminated
Research Team
D
David Chien, MD
B
Brittani Agostini, RN, CCRC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here