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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05970497
Recruitment Status : Recruiting
First Posted : August 1, 2023
Last Update Posted : March 12, 2024
Sponsor:
Information provided by (Responsible Party):
Krystal Biotech, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Melanoma Stage III Melanoma Stage IV Cutaneous Melanoma Osteosarcoma Carcinoma, Squamous Cell Carcinoma, Basal Cell Biological: KB707 Phase 1

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 Design
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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: A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study of KB707 in Subjects With Locally Advanced or Metastatic Solid Tumor Malignancies
Actual Study Start Date : October 31, 2023
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
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
 Biological: KB707
Genetically modified herpes simplex type 1 virus
Experimental: Dose expansion of KB707 by IT injection
Single-agent KB707 in superficial and deep/visceral solid tumors
 Biological: KB707
Genetically modified herpes simplex type 1 virus


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of adverse events (AEs) [ Time Frame: up to 36 months ]
    Percentage of subjects with adverse events (AEs)

  2. Percentage of serious adverse events (SAEs) [ Time Frame: up to 36 months ]
    Percentage of subjects with serious adverse events (SAEs)


Secondary Outcome Measures :
  1. 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

  2. Percentage of overall response rate (ORR) [ Time Frame: up to 36 months ]
    Percentage of ORR


Eligibility Criteria
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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 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)
Contacts and Locations
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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): NCT05970497


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, California
Mission Dermatology Center Recruiting
Rancho Santa Margarita, California, United States, 92688
Contact: Shireen Guide, MD, FAAD       admin@missiondermatology.com   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Brian Turpin, DO       cancer@cchmc.org   
United States, Pennsylvania
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Julie Urban, PhD    412-623-7396    ClinicalResearchServicesHCCIDDC@upmc.edu   
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact    844-482-4812    asksarah@sarahcannon.com   
United States, Texas
Renovatio Clinical - El Paso Recruiting
El Paso, Texas, United States, 79915
Contact: Maya Fleyhan    713-703-2398    maya.fleyhan@renovatioclinical.com   
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Li Li    713-792-3844    LLi8@mdanderson.org   
Renovatio Clinical - The Woodlands 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
More Information
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Responsible Party: Krystal Biotech, Inc.
ClinicalTrials.gov Identifier: NCT05970497    
Other Study ID Numbers: KB707-01
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: March 12, 2024
Last Verified: February 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
Krystal Biotech
cancer
Additional relevant MeSH terms:
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Carcinoma
Melanoma
Osteosarcoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Neoplasms
Neoplasms by Site
Skin Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Neoplasms, Squamous Cell
Neoplasms, Basal Cell