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

Launched by KRYSTAL BIOTECH, INC. · Jul 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called KB707 for adults with certain types of cancer, specifically those whose cancer has either spread or is difficult to treat with standard therapies. The study aims to find out how safe KB707 is and how well it works when injected directly into the tumors of patients who have not had success with other treatments, cannot tolerate them, or do not have any other treatment options available.

To participate, individuals must be at least 18 years old, have a confirmed diagnosis of a specific type of solid tumor, and have a life expectancy of more than 12 weeks. They should also have at least one tumor that can be safely injected. Participants will receive KB707 as an injection into their tumors and will be monitored for any side effects and how well the treatment works. This trial is currently recruiting participants, and it provides a new option for those who are facing challenging cancer situations.

Gender

ALL

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