Testing the Addition of an Anti-Cancer Drug, Camonsertib, to Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma

Launched by NATIONAL CANCER INSTITUTE (NCI) ·

Keywords

ClinConnect Summary

This early-phase trial is testing whether adding a drug called camonsertib to a precise form of radiation therapy (stereotactic body radiotherapy, or SBRT) is safe for people whose head and neck cancer has come back after treatment or cannot be removed by surgery. Camonsertib is an oral drug that may help stop cancer cells from growing. The study uses a dose-escalation design to find the safest and potentially best dose when combined with SBRT. Patients will receive SBRT twice a week for 3 weeks (4 or 5 radiation sessions total) and take camonsertib by mouth once daily on the day of and the day after each radiation session. The trial will also collect blood and imaging tests to understand how the drug behaves in the body and how the cancer responds, with follow-up visits planned after treatment.

Who may be eligible includes adults 18 and older with recurrent or second‑primary unresectable squamous cell cancer in parts of the head and neck (such as the mouth, throat, voice box, or sinuses) or cervical lymph nodes with unknown primary, and whose disease is in a previously irradiated area (having completed prior radiotherapy at least 6 months earlier). They need at least one measurable tumor, adequate organ function, an ECOG performance status of 0–2, and no distant metastases. Key exclusions include not having recovered from prior cancer therapy side effects, having other investigational drugs, more than one prior course of head and neck radiotherapy, tumors closely surrounding the carotid artery, pregnancy, or certain drug interactions. The main goals are to assess safety and tolerability and to determine the recommended dose for future study, with secondary aims including how many patients respond within the radiation field and how long they stay progression-free, plus exploration of biomarkers that might predict response.

Gender

ALL

Eligibility criteria