KB707 is a genetically modified herpes simplex type 1 virus that is designed to stimulate an anti-tumor immune response through the production of cytokines. This is a first-in-human (FIH) clinical study to evaluate the safety and tolerability and preliminary efficacy of KB707 in adult subjects with advanced and/or refractory solid tumors, including advanced melanoma. The study will include a dose escalation portion for single agent KB707 and an expansion portion to further evaluate KB707 at a dose determined by preliminary data in the dose escalation phase.
Key Inclusion Criteria:
* 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.
* Age 12 years or older at the time of informed consent
* Life expectancy \>12 weeks
* ECOG performance status of 0 or 1
* Have measurable disease per RECIST v1.1 at Screening
* Histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system (8th edition; AJCC 2017)
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)
* The subject must not have active brain metastases or leptomeningeal metastases
* Subject has a known additional malignancy that is progressing or requires active treatment.
* Prior anti-LAG-3/anti-PD-1 therapy was intolerable and required discontinuation of treatment
* Subject has uveal/ocular melanoma
