Assessing KB707 for treating advanced melanoma and solid tumors

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

This study is testing a new treatment called KB707, which is a modified virus, to see if it can help adults with advanced melanoma and other solid tumors who haven't had success with regular treatments.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Krystal Biotech, Inc. (industry)
• Drugs / interventions: radiation
• Locations: 15 sites (Los Angeles, California and 14 other locations)
• Trial ID: NCT05970497 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults with unresectable or metastatic melanoma who have previously failed standard therapies.

Not a fit: Patients with early-stage melanoma or those who have not yet undergone standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced melanoma and other solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies using genetically modified viruses for cancer treatment have shown promise, indicating potential for success in this novel approach.

Eligibility criteria

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 this trial is running

Los Angeles, California and 14 other locations

• 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)
• Morristown Medical Center / Atlantic Health System — Morristown, New Jersey, United States (RECRUITING)
• Weill Cornell Medicine-New York-Presbyterian Hospital — New York, New York, United States (RECRUITING)
• Gabrail Cancer Center Research — Canton, Ohio, United States (RECRUITING)
• Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (RECRUITING)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (RECRUITING)
• Renovatio Clinical - El Paso — El Paso, Texas, United States (RECRUITING)
• MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
• Renovatio Clinical - The Woodlands — The Woodlands, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: David Chien, MD

Conditions: Cancer, Melanoma Stage III, Melanoma Stage IV, Cutaneous Melanoma, Krystal Biotech, cancer, melanoma