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A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
Sponsor: Krystal Biotech, Inc.
Summary
KB707-01 is a Phase 1/2, open-label, multicenter, dose escalation and expansion study. The study will 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 as well as the safety, tolerability, preliminary efficacy, and immunologic effect of KB707 administered in combination with Opdualag to subjects with unresectable or metastatic melanoma. Subjects in dose escalation (Cohorts 1 through 3) and dose expansion (Cohort 4) will receive intratumoral injections of KB707 approximately every three weeks. Cohorts 1 through 4 are closed to new enrollment. Dose expansion Cohort 5 and Cohort 6 will evaluate subjects with advanced melanoma. Subjects in Cohort 5 will receive intratumoral injections of KB707 biweekly (q2w), delivered in combination with Opdualag (dosed every q4w per prescribing information). Subjects in Cohort 6 will receive intratumoral injections of KB707 biweekly (q2w), delivered in combination with Keytruda (dosed every q6w per prescribing information). All subjects will be treated until disease 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.
Official title: A Phase 1/2, Open-Label, Multi-Center, Dose Escalation and Expansion Study of KB707 in Subjects With Locally Advanced or Metastatic Solid Tumor Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2023-10-31
Completion Date
2027-07
Last Updated
2025-05-18
Healthy Volunteers
No
Interventions
KB707
Genetically modified herpes simplex type 1 virus
Opdualag
Dual immunotherapy (PD-1 and LAG-3 immune checkpoint inhibitors)
KEYTRUDA ®( Pembrolizumab)
Immunotherapy (PD-1 immune checkpoint inhibitor)
Locations (15)
UCLA Health
Los Angeles, California, United States
Mission Dermatology Center
Rancho Santa Margarita, California, United States
BRCR Global
Weston, Florida, United States
IU Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Henry Ford Cancer Institute
Detroit, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Morristown Medical Center / Atlantic Health System
Morristown, New Jersey, United States
Weill Cornell Medicine-New York-Presbyterian Hospital
New York, New York, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Renovatio Clinical - El Paso
El Paso, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Renovatio Clinical - The Woodlands
The Woodlands, Texas, United States