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History of Changes for Study: NCT06228326
A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
Latest version (submitted May 15, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 18, 2024 None (earliest Version on record)
2 January 26, 2024 Outcome Measures and Study Status
3 April 20, 2024 Study Status, Contacts/Locations and Outcome Measures
4 May 15, 2024 Contacts/Locations and Study Status
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Study NCT06228326
Submitted Date:  January 18, 2024 (v1)
Open or close this module Study Identification
Unique Protocol ID: KB707-02
Brief Title: A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
Official Title: KB707-02: A Phase 1 Study of Inhaled KB707 in Patients With Advanced Solid Tumor Malignancies Affecting the Lungs
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2024
Overall Status: Recruiting
Study Start: February 2024
Primary Completion: February 2027 [Anticipated]
Study Completion: February 2027 [Anticipated]
First Submitted: January 18, 2024
First Submitted that
Met QC Criteria:		 January 18, 2024
First Posted: January 29, 2024 [Actual]
Last Update Submitted that
Met QC Criteria:		 January 18, 2024
Last Update Posted: January 29, 2024 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Krystal Biotech, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: 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
Keywords: solid tumors
cancer
Krystal Biotech
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 80 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. To evaluate the safety and tolerability of inhaled KB707
[ Time Frame: up to 36 months ]

Percentage of subjects with treatment-related adverse events (AEs)
Secondary Outcome Measures:
1. To evaluate whether the proposed dose ranges include the maximum tolerated dose of KB707
[ Time Frame: up to 36 months ]

Incidence of dose limiting toxicity (DLT) by dose cohorts
2. To evaluate the preliminary efficacy of inhaled KB707
[ Time Frame: up to 36 months ]

Percentage of overall response rate (ORR)
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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)
Open or close this module Contacts/Locations
Central Contact Person: David Chien, MD
Telephone: 412-586-5830
Email: dchien@krystalbio.com
Central Contact Backup: Brittani Agostini, RN, CCRC
Telephone: 412-586-5830
Email: bagostini@krystalbio.com
Study Officials: David Chien, MD
Study Director
Senior Vice President of Clinical Development
Locations: United States, Texas
Renovatio Clinical
[Not yet recruiting]
El Paso, Texas, United States, 79915
Contact:Contact: Maya Fleyhan 713-703-2398 maya.fleyhan@renovatioclinical.com
Renovatio Clinical
[Recruiting]
The Woodlands, Texas, United States, 77380
Contact:Contact: Maya Fleyhan 713-703-2398 maya.fleyhan@renovatioclinical.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services