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Trial record 1 of 2 for:    kb707
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A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs

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ClinicalTrials.gov Identifier: NCT06228326
Recruitment Status : Recruiting
First Posted : January 29, 2024
Last Update Posted : January 30, 2024
Sponsor:
Information provided by (Responsible Party):
Krystal Biotech, Inc.

Brief Summary:
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. This Phase 1, open-label, multicenter, dose escalation and expansion study is designed to evaluate the safety and tolerability of KB707 in adults with with advanced solid tumor malignancies affecting the lungs who have progressed on standard of care therapy, cannot tolerate standard of care therapy, or refused standard of care therapy. The study will include a dose escalation portion for single agent KB707 using a standard 3+3 design followed by an expansion portion to further evaluate single agent KB707 at a dose determined by preliminary data in the dose escalation phase. Subjects in both the dose escalation and dose expansion cohorts will receive KB707 via nebulization weekly for three weeks, then every three weeks for up to two years 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.

Condition or disease Intervention/treatment Phase
Lung Cancer, Non-small Cell Lung Cancer Metastatic Solid Tumor, Adult Advanced Cancer Lung Cancer, Small Cell Metastatic Colorectal Cancer Metastatic Renal Cell Carcinoma Metastatic Hepatocellular Carcinoma Metastatic Sarcoma Metastatic Osteosarcoma Biological: KB707 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: KB707-02: A Phase 1 Study of Inhaled KB707 in Patients With Advanced Solid Tumor Malignancies Affecting the Lungs
Estimated Study Start Date : February 2024
Estimated Primary Completion Date : February 2027
Estimated Study Completion Date : February 2027


Arm Intervention/treatment
Experimental: Dose Escalation of KB707 Administered via Nebulization
Dose escalation of single-agent KB707 in 3 cohorts in a standard 3+3 design.
Biological: KB707
Genetically modified herpes simplex type 1 virus

Experimental: Dose Expansion of KB707 Administered via Nebulization
Dose expansion of single-agent KB707 in approximately 60 subjects with advanced solid tumor malignancies affecting the lungs, including approximately 40 subjects with non-small cell lung cancer.
Biological: KB707
Genetically modified herpes simplex type 1 virus




Primary Outcome Measures :
  1. To evaluate the safety and tolerability of inhaled KB707 based upon assessment of adverse events (AEs), and changes from baseline in vital signs and clinical laboratory test results [ Time Frame: up to 36 months ]
    Percentage of subjects with treatment-related AEs as assessed by NCI-CTCAE v5


Secondary Outcome Measures :
  1. To evaluate whether the proposed dose ranges include the maximum tolerated dose of KB707 as determined by incidence of dose limiting toxicities (DLTs) [ Time Frame: up to 36 months ]
    Incidence of dose limiting toxicity (DLT) by dose cohorts

  2. To evaluate the preliminary efficacy of inhaled KB707 as determined by overall response rate (ORR) [ Time Frame: up to 36 months ]
    Percentage of ORR for all participants



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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 there is no standard of care therapy.
  • 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 lesion per RECIST v1.1 at Screening

Key Exclusion Criteria:

  • Prior oncology therapy (chemotherapy, immunotherapy, biological therapy) or use of an investigational agent or an investigational device within 21 days or 5 half-lives before administration of first dose of KB707, whichever is shorter
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06228326


Contacts
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Contact: David Chien, MD 412-586-5830 dchien@krystalbio.com
Contact: Brittani Agostini, RN, CCRC 412-586-5830 bagostini@krystalbio.com

Locations
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United States, Texas
Renovatio Clinical Not yet recruiting
El Paso, Texas, United States, 79915
Contact: Maya Fleyhan    713-703-2398    maya.fleyhan@renovatioclinical.com   
Renovatio Clinical Recruiting
The Woodlands, Texas, United States, 77380
Contact: Maya Fleyhan    713-703-2398    maya.fleyhan@renovatioclinical.com   
Sponsors and Collaborators
Krystal Biotech, Inc.
Investigators
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Study Director: David Chien, MD Senior Vice President of Clinical Development
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Responsible Party: Krystal Biotech, Inc.
ClinicalTrials.gov Identifier: NCT06228326    
Other Study ID Numbers: KB707-02
First Posted: January 29, 2024    Key Record Dates
Last Update Posted: January 30, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Krystal Biotech, Inc.:
solid tumors
cancer
Krystal Biotech
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Renal Cell
Osteosarcoma
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Adenocarcinoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Carcinoma, Bronchogenic
Bronchial Neoplasms