Phase 12 Study of Inhaled KB707 for Treating Advanced Solid Tumors in the Lungs with or without Keytruda and Chemotherapy

What this Trial Is About

Researchers are studying KB707, a genetically modified herpes simplex virus type 1 HSV-1 vector designed to trigger an immune response against tumors in the lungs. This Phase 12 open-label trial evaluates the safety, tolerability, early effectiveness, and immune effects of KB707 in adults with advanced solid tumors affecting the lungs, including non-small cell lung cancer NSCLC. The study focuses on patients who have progressed on or cannot tolerate standard treatments or have refused them. Participants receive KB707 inhaled through nebulization, delivering the therapy directly to the lungs. The study has multiple parts dose escalation and expansion cohorts using KB707 alone, and additional cohorts combining KB707 with Keytruda an immune checkpoint inhibitor or chemotherapy drugs, such as docetaxel. Treatment schedules vary by cohort, with KB707 given weekly or every two to three weeks alongside other therapies, continuing until tumor progression or other specified reasons for stopping. During the study, participants undergo assessments to monitor safety and side effects, including tracking adverse events for up to 36 months. Researchers also evaluate tumor response and immune activity. Treatment continues as long as it is tolerated and beneficial, with regular evaluations to measure overall response and detect dose-related toxicities. The study is ongoing through July 2028, with participants receiving close monitoring throughout.

A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs