Phase 12 Study of STX-001 by Intratumoral Injection in Adults with Advanced Solid Tumors, Alone or with Pembrolizumab

What this Trial Is About

Researchers are evaluating STX-001, a new investigational treatment delivered directly into tumors, alone or combined with pembrolizumab, in patients with advanced solid tumors. This Phase 12 open-label trial aims to assess the safety, tolerability, how the drug moves and acts in the body, and early signs of anti-tumor effects. The study includes patients with different types of advanced cancers, including specific groups for triple-negative breast cancer and melanoma. The study is divided into several parts. Phase 1 involves dose escalation of STX-001 as monotherapy and in combination with pembrolizumab, including cohorts targeting visceral lesions. Phase 2 expands dosing in patients with triple-negative breast cancer and melanoma, further evaluating STX-001 combined with pembrolizumab and selecting the recommended dose based on earlier results. Treatments are given by intratumoral injection, possibly into multiple tumor sites, with dose extensions and treatment pauses allowed, lasting up to 35 cycles over approximately 24 months. Participants will undergo assessments including safety monitoring, blood tests, tumor biopsies before and after injections, and imaging to evaluate tumor response. Researchers will track side effects, laboratory values, drug levels, immune cell activity in tumors, and anti-tumor activity up to 18 months after the last dose. The study involves multiple visits and monitoring periods to gather detailed information on the investigational treatments effects and safety.

Phase 1/2 Study of Intratumoral Injection of STX-001 in Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab