Actively Recruiting
Phase 1 Study of Camonsertib With Targeted Radiation Therapy for Recurrent or Unresectable Head and Neck Squamous Cell Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-08-05
39
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and best dose of camonsertib combined with stereotactic body radiation therapy SBRT in patients with recurrent or unresectable head and neck squamous cell carcinoma. This phase I trial aims to better control the disease by blocking enzymes needed for tumor cell growth and precisely delivering radiation to tumors while sparing normal tissue. The study also explores biomarkers and pharmacokinetics related to this treatment combination. Participants receive 4 or 5 treatment sessions of SBRT twice a week over three weeks. Camonsertib is taken orally once daily on the day of and the day after each radiation treatment. Throughout the trial, patients undergo imaging scans such as PETCT or CT and have blood samples collected to monitor treatment effects and safety. After completing treatment, participants are followed up regularly at weeks 4, 5, 6, 7, 16, 29, 42, and 55 to assess outcomes. Researchers measure adverse events, maximum tolerated dose, late toxicities, overall response rate, and progression-free survival. This close monitoring helps evaluate the treatments impact and safety over time.
CONDITIONS
Brief Title
Testing the Addition of an Anti-Cancer Drug, Camonsertib, to Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma
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