A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory/Recurrent Metastatic Solid Tumors

What this Trial Is About

Researchers are studying STRO-004, an investigational drug, to evaluate its safety and early anti-tumor effects in adults with metastatic or recurrent solid tumors. This includes several cancer types such as head and neck squamous cell carcinoma, non-small cell lung cancer, esophageal/gastric cancer, colorectal cancer, pancreatic ductal adenocarcinoma, cervical, endometrial, and urothelial cancers. The study is open-label and includes multiple parts to assess STRO-004 alone and in combination with pembrolizumab. The trial has three parts: Part 1A is a dose escalation of STRO-004 alone to find safe doses in selected tumor types that express Tissue Factor. Part 1B expands the study in one or more cancer types to further evaluate the dose and assess anti-tumor activity. Part 1C explores dose escalation of STRO-004 combined with pembrolizumab to study tolerability and preliminary effects of the combination. Both drugs are given by intravenous infusion. Participants will undergo regular assessments including monitoring for side effects, clinical lab tests, and imaging to measure tumor response by RECIST 1.1 criteria. Researchers will track dose-limiting toxicities, treatment-emergent adverse events, progression-free survival, and survival rates up to 12 months. Blood samples will be collected to study drug levels and immune response. The study lasts up to a year with close safety and activity monitoring throughout.

A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer