NCT05970497 · Krystal Biotech, Inc.
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
What this study is about
KB707-01 is a Phase 1/2, where both patients and doctors know the treatment given, conducted at multiple hospitals, gradually increasing doses and expansion study.
View original scientific description
KB707-01 is a Phase 1/2, open-label, multicenter, dose escalation and expansion study.
Interventions
BIOLOGICAL
KB707
Genetically modified herpes simplex type 1 virus
DRUG
Opdualag
Dual immunotherapy (PD-1 and LAG-3 immune checkpoint inhibitors)
DRUG
KEYTRUDA ®( Pembrolizumab)
Immunotherapy (PD-1 immune checkpoint inhibitor)
Primary outcome measures
Percentage of adverse events (AEs)
Time frame: up to 36 months
Percentage of subjects with adverse events (AEs)
Percentage of serious adverse events (SAEs)
Time frame: up to 36 months
Percentage of subjects with serious adverse events (SAEs)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Life expectancy \>12 weeks
- ECOG performance status of 0 or 1
- Have measurable disease per RECIST v1.1 at Screening
- Cohorts 1-4 only: 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.
- Cohorts 5 and 6 only: Histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system (8th edition; AJCC 2017) and 1. Subject has previously failed one prior anti-PD-1/PD-L1 treatment (as monotherapy or in combination with other checkpoint inhibitors such as anti-LAG-3 or anti-CTLA-4); and 2. If proto-oncogene B-Raf (BRAF) V600 mutation-positive, subject previously failed a BRAF inhibitor or BRAF inhibitor in combination with mitogen-activated extracellular signal-regulated kinase (MEK) i
Where
- Los Angeles, California
- Rancho Santa Margarita, California
- Weston, Florida
- Indianapolis, Indiana
- Detroit, Michigan
- Omaha, Nebraska
- Morristown, New Jersey
- New York, New York
- Canton, Ohio
- Cleveland, Ohio
- Pittsburgh, Pennsylvania
- Nashville, Tennessee
And 3 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2025 · Source of record for eligibility and locations