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Trial record 2 of 2 for:    kb707
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A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT05970497
Recruitment Status : Recruiting
First Posted : August 1, 2023
Last Update Posted : May 9, 2024
Sponsor:
Information provided by (Responsible Party):
Krystal Biotech, Inc.

Tracking Information
First Submitted Date  ICMJE July 24, 2023
First Posted Date  ICMJE August 1, 2023
Last Update Posted Date May 9, 2024
Actual Study Start Date  ICMJE October 31, 2023
Estimated Primary Completion Date July 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2023)
  • Percentage of adverse events (AEs) [ Time Frame: up to 36 months ]
    Percentage of subjects with adverse events (AEs)
  • Percentage of serious adverse events (SAEs) [ Time Frame: up to 36 months ]
    Percentage of subjects with serious adverse events (SAEs)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2023)
  • Maximum tolerated dose (MTD) [ Time Frame: up to 36 months ]
    Assess whether the tested doses include the maximum tolerated dose (MTD) of KB707 based on the safety and response data collected during the dose escalation portion of the study
  • Percentage of overall response rate (ORR) [ Time Frame: up to 36 months ]
    Percentage of ORR
Original Secondary Outcome Measures  ICMJE Same as current
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 Locally Advanced or Metastatic Solid Tumors
Official Title  ICMJE A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study of KB707 in Subjects With Locally Advanced or Metastatic Solid Tumor Malignancies
Brief Summary KB707-01 is a Phase 1, open-label, multicenter, dose escalation and expansion study to evaluate the safety and tolerability of KB707 in adults with locally advanced or metastatic solid tumors who have progressed on standard of care therapy, cannot tolerate standard of care therapy, refused standard of care therapy, or for whom there is no standard of care therapy. In this study, patients will receive KB707 via direct intratumoral (IT) injection into solid tumors to assess the safety and tolerability as well preliminary efficacy of KB707 monotherapy treatment.
Detailed Description KB707 is a genetically modified herpes simplex type 1 virus that is designed to stimulate an anti-tumor immune response through the production of cytokines. This is a first-in-human (FIH) clinical study to evaluate the safety and tolerability, biodistribution, shedding, and preliminary efficacy of KB707 in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation portion for single agent KB707 and an expansion portion to further evaluate single agent KB707 at a dose determined by preliminary data in the dose escalation phase.
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
  • Cancer
  • Melanoma Stage III
  • Melanoma Stage IV
  • Cutaneous Melanoma
  • Osteosarcoma
  • Carcinoma, Squamous Cell
  • Carcinoma, Basal Cell
Intervention  ICMJE Biological: KB707
Genetically modified herpes simplex type 1 virus
Study Arms  ICMJE
  • Experimental: Dose escalation of KB707 by intratumoral (IT) injection in solid tumors
    Dose escalation of single-agent KB707 in 3 cohorts to treat superficial solid tumors
    Intervention: Biological: KB707
  • Experimental: Dose expansion of KB707 by IT injection
    Single-agent KB707 in superficial and deep/visceral solid tumors
    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: July 24, 2023)		 80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2026
Estimated Primary Completion Date July 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor 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
  • ECOG performance status of 0 or 1
  • Have at least one measurable and injectable tumor that is accessible by transcutaneous administration

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 NCT05970497
Other Study ID Numbers  ICMJE KB707-01
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 May 2024

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