Assessing KB707 for treating advanced melanoma and solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1/2, open-label, multicenter clinical trial evaluating the safety and tolerability of KB707, a genetically modified herpes simplex virus, in adults with locally advanced or metastatic solid tumors. The study includes a dose escalation phase and an expansion phase, where participants receive intratumoral injections of KB707, either alone or in combination with the immune checkpoint inhibitor Opdualag. The trial aims to assess the preliminary efficacy and immunologic effects of KB707 in patients who have progressed on or cannot tolerate standard therapies.

Why it matters

Who can join: the full rules

Key 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) inhibitor
* 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

Key Exclusion Criteria:

* 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:

  1. Subject has a known additional malignancy that is progressing or requires active treatment.
  2. Subject has uveal/ocular melanoma.
  3. The subject has active brain metastases or leptomeningeal metastases
  4. Subject has received more than 2 lines of systemic therapy for unresectable or metastatic melanoma
  5. Prior anti-LAG-3 and/or anti-PD-1 therapy was intolerable and required discontinuation of treatment

Where it's running

• UCLA Health
  Los Angeles, California, United States Recruiting
• Mission Dermatology Center
  Rancho Santa Margarita, California, United States Recruiting
• BRCR Global
  Weston, Florida, United States Recruiting
• IU Simon Comprehensive Cancer Center
  Indianapolis, Indiana, United States Recruiting
• Henry Ford Cancer Institute
  Detroit, Michigan, United States Recruiting
• University of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting

Study contacts

• Study coordinator: David Chien, MD
• Email: dchien@krystalbio.com
• Phone: 412-586-5830

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.