Enrolled patients will receive upfront (week 1) short-course radiotherapy to gross pelvic disease (25Gy in 5fx) in combination with AB928 (150 mg orally, once daily as part of a continuous dose regimen). This will be followed by consolidation chemotherapy (weeks 3-20) with mFOLFOX x9 cycles in combination with AB928 and AB122.
Histologically confirmed diagnosis of adenocarcinoma of the rectum
Age ≥ 18 years
ECOG performance status 0-1
cT3N0 or cT1-3N1 or cT4 or cN2
Recurrent rectal cancer
Primary unresectable rectal cancer is defined as a primary rectal tumor which, on the basis of either physical exam or pelvic MRI, is demed to be adherent or fixed to adjacent pelvic structures (en bloc resection wll not be achieved with negative margins).
Involved radial margin
Serum creatinine level >1.5x the upper limit of normal
Weill Medical College of Cornell University
Lead sponsor
Arcus Biosciences, Inc.
Collaborator