It is also anticipated that subject accrual rate for the remaining six subjects will be one subject every 20 days. Based on this rate it will take approximately 4 months to accrue a total of 10 subjects. Since subjects are followed for 38 weeks after the PolyPEPI 1018 initial vaccination , the total duration of the study is approximately 14 months from the date of amendment, that is approximately 17 months from the initiation of the OBERTO study. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 33 of 81 CONFIDENTIAL 3.4 Randomization and Blinding This is a non-randomized, open- label study. 3.5 Study Stopping Rules The sponsor has the right to terminate the study at any time. The study will be stopped if any of the following occur: • New information leading to an unfavorable risk-benefit judgement of PolyPEPI1018, including the following ( applicable after every vaccination and every five patients) : o 3 or more DLTs within 21 days of peptide vaccine administration o 1 or more deaths (other than death related to progressive disease) that occurs within 30 days of peptide vaccine administration o Other unfavorable safety findings • Sponsor’s decision that continuation of the study is unjustifiable for medical or ethical reasons • Poor enrollment of subjects making completion of the study withi n an acceptable time frame unlikely • Discontinuation of the development of PolyPEPI1018 • Specific request of a health authority In accordance with applicable regulations, health authorities and Independent Ethics Committees (IECs)/Institutional Review Boards (IRBs) will be informed by the s ponsor if the study is discontinued. If a study is discontinued, the investigator will inform the subject’s primary health care provider, as applicable, to ensure the subject receives the appropriate follow-up and care. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 34 of 81 CONFIDENTIAL 4 SUBJECT SELECTION A total of 10 subject s with mCRC who have achieved partial response ( PR) or stable disease during first -line treatment with chemotherapy plus a biologic drug will be enrolled. 4.1 Inclusion Criteria Subjects who meet ALL of the following criteria are eligible for this study: 1.