This is a parallel arm adaptive design phase I-II dose-finding study to determine the optimal dose of fractionated stereotactic radiation therapy (SBRT), given either with the radiomodulating agent Avasopasem (GC4419) or placebo for treatment of locally advanced pancreatic cancer. Dose-finding will be done using the sequentially adaptive phase I-II Late onset Efficacy-Toxicity (LO-ET) trade-off-based design [1-3].~A maximum of 48 patients will be randomized 1:1 to Arm A or Arm B. Patients in Arm A will receive Avasopasem (GC4419) in combination with their assigned SBRT dose, and patients in Arm B will receive Placebo (PBO) with their assigned SBRT dose. The randomization will be restricted so that the sample size within each arm is exactly 24 patients.~GC4419/placebo will be given intravenously in a one hour infusion. SBRT must be initiated as soon as possible upon completion of the GC4419/placebo infusion.~GC4419/placebo will be given beginning on the first day of radiation and continuing daily, concurrent M-F throughout the administration of SBRT~Objectives:~Primary:~• To determine the Maximum Tolerated Dose (MTD) of Stereotactic Body Radiation Therapy (SBRT) when given in combination with placebo or GC4419~Secondary:~To evaluate Progression-free survival (PFS) at MTD for patients treated with SBRT given in combination with placebo or GC4419~To evaluate Overall Response Rate (ORR) including stable disease, partial/ complete response for patients treated with SBRT given in combination with placebo or GC4419~To evaluate late (12 month) toxicity of SBRT in combination with placebo or GC4419
The purpose of the phase I/II clinical study is to determine the best dose of fractionated stereotactic radiation therapy (SBRT) given either with Avasopasem (GC4419) or placebo to patients who have been diagnosed with locally advanced pancreatic cancer.