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Brief Title: A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
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
Study ID: NCT05970497
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford Cancer Center, Palo Alto, California, United States
Mission Dermatology Center, Rancho Santa Margarita, California, United States
IU Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States
Weill Cornell Medicine-New York-Presbyterian Hospital, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, 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
Name: David Chien, MD
Affiliation: Senior Vice President of Clinical Development
Role: STUDY_DIRECTOR