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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 : April 24, 2024
Sponsor:
Information provided by (Responsible Party):
Krystal Biotech, Inc.

Tracking Information
First Submitted Date  ICMJE January 18, 2024
First Posted Date  ICMJE January 29, 2024
Last Update Posted Date April 24, 2024
Actual Study Start Date  ICMJE April 17, 2024
Estimated Primary Completion Date February 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2024)		 To evaluate the safety and tolerability of inhaled KB707 based upon assessment of adverse events (AE) [ Time Frame: up to 36 months ]
Percentage of subjects with treatment-related AEs as assessed by NCI-CTCAE v5
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2024)		 To evaluate the safety and tolerability of inhaled KB707 [ Time Frame: up to 36 months ]
Percentage of subjects with treatment-related adverse events (AEs)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2024)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2024)
  • 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
  • To evaluate the preliminary efficacy of inhaled KB707 [ Time Frame: up to 36 months ]
    Percentage of overall response rate (ORR)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
Official Title  ICMJE KB707-02: A Phase 1 Study of Inhaled KB707 in Patients With Advanced Solid Tumor Malignancies Affecting the Lungs
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Biological: KB707
Genetically modified herpes simplex type 1 virus
Study Arms  ICMJE
  • Experimental: Dose Escalation of KB707 Administered via Nebulization
    Dose escalation of single-agent KB707 in 3 cohorts in a standard 3+3 design.
    Intervention: Biological: KB707
  • 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.
    Intervention: Biological: KB707
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 18, 2024)		 80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2027
Estimated Primary Completion Date February 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Chien, MD 412-586-5830 dchien@krystalbio.com
Contact: Brittani Agostini, RN, CCRC 412-586-5830 bagostini@krystalbio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06228326
Other Study ID Numbers  ICMJE KB707-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Krystal Biotech, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Krystal Biotech, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Chien, MD Senior Vice President of Clinical Development
PRS Account Krystal Biotech, Inc.
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP