A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
NCT ID: NCT06228326
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
250 participants
INTERVENTIONAL
2024-04-17
2028-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohorts 1 through 4
Dose escalation and expansion cohorts: KB707 monotherapy in subjects with solid tumor malignancies affecting the lungs.
KB707
Genetically modified herpes simplex type 1 virus
Cohort 5
Dose expansion cohort: KB707 administered in combination with Keytruda in approximately 60 subjects with NSCLC.
KB707
Genetically modified herpes simplex type 1 virus
Pembrolizumab (KEYTRUDA®)
PD-1 immune checkpoint inhibitor
Cohort 6
Dose expansion cohort: KB707 administered in combination with Keytruda and chemotherapy in approximately 60 subjects with NSCLC.
KB707
Genetically modified herpes simplex type 1 virus
Pembrolizumab (KEYTRUDA®)
PD-1 immune checkpoint inhibitor
Chemotherapy
SOC chemotherapy
Experimental: Cohort 7
Dose expansion cohort: KB707 administered in combination with docetaxel in approximately 50 subjects with NSCLC.
KB707
Genetically modified herpes simplex type 1 virus
Docetaxel
SOC chemotherapy
Interventions
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KB707
Genetically modified herpes simplex type 1 virus
Pembrolizumab (KEYTRUDA®)
PD-1 immune checkpoint inhibitor
Chemotherapy
SOC chemotherapy
Docetaxel
SOC chemotherapy
Eligibility Criteria
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Inclusion Criteria
* 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, 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 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 given the ICI and platinum-based chemotherapy sequentially as two separate lines.
2. Subjects 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.
Exclusion Criteria
* 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:
1. Subject has a known additional malignancy that is progressing or requires active treatment
2. Subject has active brain metastases or leptomeningeal metastases
3. Prior anti-PD-1/PD-L1 therapy was intolerable and required discontinuation of treatment
4. Subject has active, known, or suspected autoimmune disease requiring systemic treatment
5. Subject has known acute or chronic hepatitis
6. Subject has active pneumonitis or history of ICI-induced pneumonitis that required steroids
18 Years
ALL
No
Sponsors
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Krystal Biotech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Chien, MD
Role: STUDY_DIRECTOR
Senior Vice President of Clinical Development
Locations
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XCancer Research Network/Dothan Hematology & Oncology
Dothan, Alabama, United States
HonorHealth Research Institute
Scottsdale, Arizona, United States
Precision NextGen Oncology
Beverly Hills, California, United States
Emad Ibrahim MD Inc
Redlands, California, United States
BRCR Global
Weston, Florida, United States
IU Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Ochsner/MD Anderson Cancer Center
New Orleans, Louisiana, United States
Henry Ford Health
Detroit, Michigan, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nasville, Tennessee, United States
Renovatio Clinical
El Paso, Texas, United States
Renovatio Clinical
The Woodlands, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Oncology Clinical Trials Nurse Navigator
Role: backup
Amanda Woolery, RN, BSN
Role: backup
Cancer Answer Line
Role: primary
Other Identifiers
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KB707-02
Identifier Type: -
Identifier Source: org_study_id
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