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.