Phase 1 Study of STRO-004 Alone or With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and early anti-tumor effects of STRO-004 in adults with metastatic or locally advanced solid tumors that commonly express Tissue Factor. This phase 1 trial includes patients with various cancers such as head and neck squamous cell carcinoma, non-small cell lung cancer, esophageal, gastric, colorectal, pancreatic, cervical, endometrial, and urothelial cancers. The study is sponsored by Sutro Biopharma, Inc. and aims to find safe doses and assess preliminary treatment activity. The study has three parts Part 1A tests increasing doses of STRO-004 alone to find safe levels Part 1B expands to evaluate the best dose and anti-tumor activity in one or more cancer types Part 1C studies dose escalation of STRO-004 combined with pembrolizumab to check tolerability and early activity when used together. Both drugs are given by intravenous infusion. Participants may receive multiple doses during these periods. Participants will have tumor tissue samples available and measurable disease confirmed. Researchers will monitor safety through adverse events, dose-limiting toxicities, and laboratory tests for up to 12 months. They will also measure anti-tumor responses, progression-free survival, and survival rates. Blood samples will be collected to study drug levels and immune responses. Participants may be assessed regularly throughout treatment and follow-up, which may last up to a year.

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