Actively Recruiting
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
Led by Krystal Biotech, Inc. · Updated on 2025-05-18
240
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating KB707, a genetically modified herpes simplex type 1 virus designed to stimulate the immune system against tumors, in adults with advanced or metastatic solid tumors, including melanoma. This Phase 1/2, open-label study aims to assess the safety, tolerability, preliminary efficacy, and immune effects of KB707 alone and in combination with immune checkpoint inhibitors in subjects who have progressed on or cannot tolerate standard therapies. Participants in initial dose escalation and expansion cohorts receive intratumoral KB707 injections approximately every three weeks. Later cohorts evaluate KB707 given biweekly combined with either Opdualag, a dual immune checkpoint inhibitor, or Keytruda, an immune checkpoint inhibitor dosed every 4 or 6 weeks respectively. Treatment continues until disease progression, unacceptable side effects, or other study or participant decisions. Throughout the study, subjects undergo assessments for adverse events, serious adverse events, and overall response rate up to 36 months. Researchers monitor safety, tolerability, and tumor response while participants receive regular intratumoral injections and immune therapies. The study includes ongoing follow-up to evaluate treatment effects and participant health over an extended period.
CONDITIONS
Brief Title
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy greater than 12 weeks
- ECOG performance status of 0 or 1
- Measurable disease per RECIST v1.1 at screening
- For Cohorts 1-4: Histologically confirmed locally advanced or metastatic solid tumor and progressed on or cannot tolerate or refused standard therapy, or no standard therapy exists
- For Cohorts 5 and 6: Histologically confirmed stage III (unresectable) or stage IV melanoma
- For Cohorts 5 and 6: Previously failed one prior anti-PD-1/PD-L1 treatment
- For BRAF V600 mutation-positive subjects: Previously failed BRAF inhibitor or BRAF inhibitor with MEK inhibitor
- Cohort 5 only: Age 12 years or older at consent
- Cohort 6 only: Age 18 years or older at consent
You will not qualify if you...
- Not fully recovered from prior surgery or radiation therapy including all related toxicities
- Requirement for systemic corticosteroids
- Pregnant, nursing, or planning pregnancy during treatment and three months after last KB707 dose
- Known positive HIV 1/2 infection
- For Cohorts 5 and 6: Known additional progressing malignancy requiring treatment
- For Cohorts 5 and 6: Uveal or ocular melanoma
- For Cohorts 5 and 6: Active brain or leptomeningeal metastases
- For Cohorts 5 and 6: Received more than 2 lines of systemic therapy for unresectable or metastatic melanoma
- For Cohorts 5 and 6: Prior anti-LAG-3 and/or anti-PD-1 therapy was intolerable and led to discontinuation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants receive KB707 either alone or in combination with immunotherapy drugs to treat their advanced or metastatic solid tumors.
Visits occur regularly during treatment to monitor safety and response
Duration - Up to 36 months
Participants are monitored for safety and treatment effects after completion of therapy.
Periodic follow-up visits as scheduled by the study team
Trial Site Locations
Total: 15 locations
1
UCLA Health
Los Angeles, California, United States, 90095
Actively Recruiting
2
Mission Dermatology Center
Rancho Santa Margarita, California, United States, 92688
Actively Recruiting
3
BRCR Global
Weston, Florida, United States, 33326
Actively Recruiting
4
IU Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
Henry Ford Cancer Institute
Detroit, Michigan, United States, 48202
Actively Recruiting
6
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
7
Morristown Medical Center / Atlantic Health System
Morristown, New Jersey, United States, 07960
Actively Recruiting
8
Weill Cornell Medicine-New York-Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
9
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Actively Recruiting
10
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
11
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
12
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
13
Renovatio Clinical - El Paso
El Paso, Texas, United States, 79915
Actively Recruiting
14
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
15
Renovatio Clinical - The Woodlands
The Woodlands, Texas, United States, 77380
Actively Recruiting
Research Team
D
David Chien, MD
B
Brittani Agostini, RN, CCRC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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