Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

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

Details

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.

Keywords

Cancer, Melanoma Stage III, Melanoma Stage IV, Cutaneous Melanoma, Osteosarcoma, Carcinoma, Squamous Cell, Carcinoma, Basal Cell, solid tumors, Krystal Biotech, Carcinoma, Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Locations

  • UCLA Health accepting new patients
    Los Angeles California 90095 United States
  • Mission Dermatology Center accepting new patients
    Rancho Santa Margarita California 92688 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Krystal Biotech, Inc.
Links
Sign up for this study
ID
NCT05970497
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated