Phase 1 Study of IDE034 to Assess Safety and Effectiveness in Adults With Advanced or Metastatic Solid Tumors Expressing B7-H3 and PTK7

What this Trial Is About

Researchers are conducting a Phase 1a1b, open-label, multicenter clinical study to assess the safety, pharmacokinetics, immune response, and early effectiveness of IDE034 in adults with locally advanced or metastatic solid tumors that express the proteins B7-H3 and PTK7. The study focuses on several tumor types including non-small cell lung cancer, esophageal squamous cell carcinoma, endometrial cancer, high grade serous ovarian cancer, head and neck squamous cell carcinoma, triple negative breast cancer, colorectal cancer, and castration-resistant prostate cancer. The study is divided into two parts. Part 1 involves dose escalation where participants receive increasing doses of IDE034 to find the maximum tolerated dose and the recommended dose for further study. Part 2 involves dose expansion where participants receive selected safe doses to further evaluate safety, tolerability, and tumor response. A basket cohort may also be enrolled at one of the expansion doses based on emerging data and specific tumor characteristics. Participants will be closely monitored throughout the study for safety and treatment effects. Assessments include measuring tumor responses, pharmacokinetics, immunogenicity, and tolerability. The total study duration is approximately 20 months. Monitoring occurs during both dose escalation and dose expansion phases to understand the impact of IDE034 in this patient population.

A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types