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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllKrystal Biotech, Inc.
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In plain words

What the trial is, and whether it could suit you

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 (Cohor

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Key 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, 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. Key Exclusion Criteria: * 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: 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
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What it tests

  • KB707
  • Pembrolizumab (KEYTRUDA®)
  • Chemotherapy
  • Docetaxel
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Where

14 sites
XCancer Research Network/Dothan Hematology & Oncology
Dothan, United States
HonorHealth Research Institute
Scottsdale, United States
Precision NextGen Oncology
Beverly Hills, United States
Emad Ibrahim MD Inc
Redlands, United States
BRCR Global
Weston, United States
IU Simon Comprehensive Cancer Center
Indianapolis, United States
Ochsner/MD Anderson Cancer Center
New Orleans, United States
Henry Ford Health
Detroit, United States

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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