Cancer Type: Head & Neck
Study Type: Treatment
Phase: Phase I
Principal Investigator: Caudell, Jimmy
Phase I Trial With Expansion Cohort Of DNA-PK Inhibition And IMRT In Cisplatin-Ineligible Patients With Stage 3-4 Local-Regionally Advanced Head And Neck Squamous Cell Carcinoma (HNSCC)
Primary Objective: To determine the recommended phase 2 dose (RP2D) of M3814 (peposertib) when given in combination with IMRT. Secondary Objectives: To evaluate the safety and tolerability of the combination of M3814 (peposertib) with radiotherapy. To estimate the rates of grade 3 or greater acute toxicities of the regimen. To estimate late toxicities of the regimen. To evaluate the clinical response rate, based on RECIST 1.1, at 3 months post completion of radiotherapy. To estimate 6 and 12-month progression-free survival (PFS) in the dose expansion cohort (DEC). To estimate 6 and 12-month overall survival (OS) in the DEC.
Chemotherapy (NOS); Radiotherapy
IGRT (); IMRT (); M3814 Peposertib ()
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