Phase 0 Multicenter Study to Explore the Effects of Small Doses of PBA-0111 Injected Directly Into Tumors in Adults With Certain Solid Tumors

What this Trial Is About

Researchers are evaluating the effects of a drug called PBA-0111 when given in very small doses directly into tumors in patients with certain solid tumors. This Phase 0 trial focuses on head and neck squamous cell carcinoma, soft tissue sarcoma, and triple negative breast cancer. The goal is to study how PBA-0111 affects the tumor environment and triggers immune responses that may kill cancer cells. The study uses a special CIVO device that injects microdoses of PBA-0111 directly into the tumor tissue in up to eight small areas. This is done 1 to 2 days before the patients planned surgery to remove the tumor or affected lymph nodes. Alongside PBA-0111, a control solution sterile saline is also injected to compare responses. The injected tumor tissue is then removed during surgery for detailed analysis. Participants will undergo injection with the CIVO device before their surgery, after which the removed tumor samples are examined using advanced staining techniques to measure cell death and immune activity. Researchers will also monitor any adverse events for up to 28 days after injection. The study aims to understand the drugs biological effects within a short time frame and involves careful follow-up during this period.

A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors