A Study of KB707 for Advanced Solid Tumors and Melanoma

This study is testing KB707, a genetically modified virus, alone and in combination with Opdualag (a dual immunotherapy) or KEYTRUDA® (an immunotherapy). It's for adults with locally advanced or metastatic solid tumors, including melanoma, whose cancer has progressed or who can't take standard treatments. The main goal is to see how safe KB707 is by tracking side effects for up to 36 months. The study is also looking at how well KB707 works. You may be eligible if you have a life expectancy over 12 weeks and a good general health status. Cohorts 1-4, which involved KB707 alone, are currently closed to new participants.

Study design
This is a Phase 1/2, open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 240 participants.
What's involved
If you are in Cohorts 1-4 (now closed), you would have received injections of KB707 into your tumor about every three weeks.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 36 months after treatment.

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NCT05970497

A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Krystal Biotech, Inc.
~240 participants
Updated 2025-05-18 on ClinicalTrials.gov
What's tested:KB707OpdualagKEYTRUDA ®( Pembrolizumab)

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of adverse events (AEs)
Measured over up to 36 months
+1 more outcome measured
Cancer
Melanoma Stage III
Melanoma Stage IV
Cutaneous Melanoma
15 sites across 11 states
Texas3
California2
Ohio2
Florida1
Indiana1
Michigan1
Nebraska1
New Jersey1
  • David Chien, MD · STUDY_DIRECTOR · Senior Vice President of Clinical Development

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Cohort 5 only: Age 12 years or older at the time of informed consent
Cohort 6 only: Age 18 years or older at the time of informed consent

Exclusion

Prior surgery or radiation therapy must be fully recovered, including all radiation -related toxicities and subject does not require systemic corticosteroids
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)
Cohorts 5 and 6 only:
  • Percentage of adverse events (AEs)up to 36 months

    Percentage of subjects with adverse events (AEs)

  • Percentage of serious adverse events (SAEs)up to 36 months

    Percentage of subjects with serious adverse events (SAEs)