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. 


  • 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.
Group Treatment Dose Collection at n
1 Vehicle PO, QD x 21 X hours post-last dose 4
2 AE1 (Dose A) PO, QD x 21 X hours post-last dose 4
3 AE1 (Dose B) PO, QD x 21 X hours post-last dose 4


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