Phase 2 Study of Ivonescimab for Adults With Advanced or Metastatic Salivary Gland Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Ivonescimab, an antibody treatment, in adults with advanced, metastatic salivary gland cancers that cannot be cured. This phase 2, open-label study focuses on participants with recurrent or metastatic salivary gland carcinomas, including adenoid cystic carcinoma. Ivonescimab is not yet approved by the FDA for this cancer but has been used for lung cancer treatment. The study is supported by Summit Therapeutics and led by Glenn J. Hanna. Participants receive Ivonescimab through intravenous infusion once daily on day 1 of each 21-day cycle. The study involves two cohorts one with adenoid cystic carcinoma and one with other salivary gland carcinomas. About 11 participants will enroll in each cohort initially if more than two respond to treatment, enrollment continues. Imaging tests occur every 9 weeks, followed by an end-of-treatment visit and imaging. After treatment ends, participants have follow-up visits every 12 weeks. During the study, participants undergo screening, clinic visits, imaging tests such as X-rays, CT, MRI, or PET scans, blood and urine tests, and tumor biopsies. Researchers will measure the objective response rate over up to 2 years and monitor progression-free survival, overall survival, duration of response, safety, and toxicity. The total participation time is approximately 3 years, including follow-up after treatment completion to observe long-term outcomes.

A Phase 2 Trial of Ivonescimab for Patients With Advanced, Metastatic Salivary Gland Cancers