Tolerance Evaluation of Experimental Compound in Kras/p53 PDAC Mice

• Provides one or two dosing arms plus a vehicle control arm.
• Includes full toxicology report
• Includes cryopreserved tissues and blood plasma
• Takes about three months to complete.
• Includes sufficient basic consultation with a subject matter expert. 

Process

• Breed 18 KPC animals with the intent of generating a cohort of 12 animals with confirmed tumor-load matching the following enrollment criteria: 
  • Female mice are considered eligible for enrollment when ultrasound examination within 24 hours reveals 1 or 2 tumors, with the largest size being 6–11 mm and a combined tumor volume of 100–350 mm3.
  • Animals with three or more tumors per organ; cystic tumors; signs of intestinal, pancreatic, or gall bladder duct occlusions; or otherwise moribund/showing signs of dilapidation will not be included in the study. 
• Assemble and randomize tumor-bearing mice into three treatment arms.
  • Four animals per arm: vehicle, experimental compound at dose level A, and experimental compound at dose level B
  • Dosing will be oral at QDx21
• Process animals for terminal blood collection and full necropsy (at a pre-specified timepoint upon administering the last dose), following the toxicologic pathology guidelines.
• Provide cryopreserved plasma samples and tissues from PDAC tumor, lung, liver, and skeletal muscle for histology/pathology evaluation.