Phase 12 Study of KB707 Alone or With Opdualag or Keytruda for Advanced or Metastatic Solid Tumors and Melanoma

What this Trial Is About

Researchers are evaluating KB707, a genetically modified herpes simplex type 1 virus designed to stimulate the immune system against tumors, in adults with advanced or metastatic solid tumors, including melanoma. This Phase 12, open-label study aims to assess the safety, tolerability, preliminary efficacy, and immune effects of KB707 alone and in combination with immune checkpoint inhibitors in subjects who have progressed on or cannot tolerate standard therapies. Participants in initial dose escalation and expansion cohorts receive intratumoral KB707 injections approximately every three weeks. Later cohorts evaluate KB707 given biweekly combined with either Opdualag, a dual immune checkpoint inhibitor, or Keytruda, an immune checkpoint inhibitor dosed every 4 or 6 weeks respectively. Treatment continues until disease progression, unacceptable side effects, or other study or participant decisions. Throughout the study, subjects undergo assessments for adverse events, serious adverse events, and overall response rate up to 36 months. Researchers monitor safety, tolerability, and tumor response while participants receive regular intratumoral injections and immune therapies. The study includes ongoing follow-up to evaluate treatment effects and participant health over an extended period.

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