Trial Title:
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
NCT ID:
NCT05970497
Condition:
Cancer
Melanoma Stage III
Melanoma Stage IV
Cutaneous Melanoma
Osteosarcoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Conditions: Official terms:
Carcinoma
Melanoma
Osteosarcoma
Carcinoma, Squamous Cell
Carcinoma, Basal Cell
Conditions: Keywords:
solid tumors
Krystal Biotech
cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
KB707
Description:
Genetically modified herpes simplex type 1 virus
Arm group label:
Dose escalation of KB707 by intratumoral (IT) injection in solid tumors
Arm group label:
Dose expansion of KB707 by IT injection
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.
Criteria for eligibility:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA Health
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Youstina Zaki
Phone:
310-794-3102
Email:
YZaki@mednet.ucla.edu
Contact backup:
Last name:
Elizabeth Seja
Phone:
310-794-6892
Email:
ESeja@mednet.ucla.edu
Facility:
Name:
Stanford Cancer Center
Address:
City:
Palo Alto
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sunil Reddy, MD
Phone:
(650) 498-6000
Email:
Sreddy@stanford.edu
Facility:
Name:
Mission Dermatology Center
Address:
City:
Rancho Santa Margarita
Zip:
92688
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shireen Guide, MD, FAAD
Email:
admin@missiondermatology.com
Facility:
Name:
IU Simon Comprehensive Cancer Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anne Younger, RN
Phone:
(317) 274-0951
Email:
anefoste@iupui.edu
Contact backup:
Last name:
Yvonne LaFary, RN
Phone:
(317) 278-5613
Email:
ylafary@iu.edu
Facility:
Name:
Henry Ford Cancer Institute
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Morristown Medical Center / Atlantic Health System
Address:
City:
Morristown
Zip:
07960
Country:
United States
Status:
Recruiting
Contact:
Last name:
Salome Geene, RN, CRC, BSN
Phone:
973-971-6373
Email:
salome.geene@atlantichealth.org
Facility:
Name:
Weill Cornell Medicine-New York-Presbyterian Hospital
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anna C Pavlick, DO
Phone:
(646) 962-6444
Facility:
Name:
Cincinnati Children's Hospital Medical Center
Address:
City:
Cincinnati
Zip:
45229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Turpin, DO
Email:
cancer@cchmc.org
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer Answer Line
Phone:
216-444-7923
Facility:
Name:
UPMC Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julie Urban, PhD
Phone:
412-623-7396
Email:
ClinicalResearchServicesHCCIDDC@upmc.edu
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Phone:
(844) 482-4812
Email:
asksarah@sarahcannon.com
Facility:
Name:
Renovatio Clinical - El Paso
Address:
City:
El Paso
Zip:
79915
Country:
United States
Status:
Recruiting
Contact:
Last name:
Randa Madero
Phone:
713-703-2398
Email:
Randa.madero@renovatioclinical.com
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Li Li
Phone:
713-792-3844
Email:
LLi8@mdanderson.org
Facility:
Name:
Renovatio Clinical - The Woodlands
Address:
City:
The Woodlands
Zip:
77380
Country:
United States
Status:
Recruiting
Contact:
Last name:
Randa Madero
Phone:
713-703-2398
Email:
Randa.madero@renovatioclinical.com
Start date:
October 31, 2023
Completion date:
July 2026
Lead sponsor:
Agency:
Krystal Biotech, Inc.
Agency class:
Industry
Source:
Krystal Biotech, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05970497
