Zlecenie 7197336 - Zapytanie ofertowe 29 11 2019 E - service: Maximum tolerated...

sment in tumor bearing mice Cel zamówienia Celem zamówienia jest realizacja usługi służącej do realizacji badań w projekcie pt. "Nowa generacja immunoterapii nowotworów oparta o aktywację odpowiedzi immunologicznej pacjentów" Przedmiot zamówienia Maximum tolerated dose assessment in tumor bearing mice
1.1 Animals will be inoculated subcutaneously with a selected cell lines, preferably CT26, MC38 and LLC (LL/2). Optionally, other models (e.g. EMT6, B16F10, Pan02, A20, 4T1) should be also available. Contractor should specify which syngeneic models are available; only proposals including at least 6 of the mentioned models will be accepted.

1.2 Animals
Female mice of C57BL/6 or Balb/c strain (depending on the tumor cell line), age-matched, n=6 per experimental group. Contractor must deliver mice from Charles River Laboratory or Jackson Laboratory. Other Vendors will not be accepted unless equivalent mice can be delivered, i.e. mice with published comparable gut microbiota to CRL and JAX mice. The offers without proper certifications will be excluded.

1.3 Compound administration
Randomization will be performed when mean tumor volume will reach ~80-120 mm3, within range 55-150 mm3. The compounds will be provided by the Sponsor together with formulation instructions.
The compounds will be provided by the Sponsor together with formulation instructions. Compound(s) will be prepared freshly before dosing. Compound or formulation will be administered SC or IV, with QD, EOD, E3D, E4D or E5D schedule. Total number of doses will not exceed 7.
Depending on the administration scheme, maximum dosing phase of 7 days (QD), 13 days (EOD), 19 days (E3D), 25 days (E4D) or 31 days (E5D) should be assumed. In each case, dosing period will be followed by the additional observation period for up to 7 days post last dose.

Contractor must specify additional costs (if any) for dosing on Saturday and/or Sunday. Differences in pricing between administration routes, schemes and study duration (including observation period) should be clearly stated.

1.4 General study plan
The study plan includes:
N=6 mice per treatment group; minimum number of groups per study will be 4, maximum 10. Dosing period will be followed by 7 days of monitoring. Body weights have to be measured and recorded daily, clinical observations have to be recorded daily, tumor volume measurements have to be performed and recorded 3 times per week.

1.5 Evaluated parameters
Clinical signs and individual body weights (BW) will be monitored daily, independent of the administration scheme, both during the dosing phase and during the observation period. Tumor volumes (TV) will be measured at least three times per week for up to 7 days post randomization OR until HE is reached. Contractor should inform about the raw data availability during the study course and updates frequency.

1.6 Sample collection and shipment
Survival blood sampling (plasma) should be quoted, per mouse per occasion. Sampling may be requested after the first and the last dose administration.

Samples should be stored at -80oC until shipment on dry ice to Sponsor. Shipment costs to Poland should be included in the quotation. It should be stressed, that the permission from Central Veterinary Inspectorate is obligatory to import biological samples from outside the European Union, which will be the responsibility of the Sponsor.

1.7 Report
Non-GLP study report is an option. Regular at least weekly updates are compulsory.

The Ordering Party reserves the right to order from 1 to 10 single MTD studies with varying number of experimental groups ranging from 4 to 10 per single study. The total number of mice used in all studies may not exceed 240.
Contractor should declare the possibility to utilize about 240 mice within 18 months.