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CONTACT
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed adenocarcinoma originating from the colon or rectum
Metastatic disease (Stage IV American Joint Committee on Cancer, Version 7)
Confirmed MSS and/or proficient mismatch repair (MMR) status
Experienced disease progression during or within 3 months following the last administration of systemic anti-cancer therapies for metastatic disease
Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Life expectancy estimated by the Investigator to be \>=12 weeks
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
Adequate cardiovascular, hematological and renal function and laboratory parameters
You may not be if
Pregnant or breastfeeding or intending to become pregnant
Participants with active central nervous system (CNS) metastases
History of malignancy other than the one under investigation
Any unresolved toxicities from prior therapy, i.e., radiotherapy, chemotherapy, targeted therapy or surgical procedure
Major surgery or significant traumatic injury \<4 weeks prior to the first CEA-PRIT 2.0 administration (excluding biopsies) or anticipation of the need for major surgery during study treatment
Participants have a known confirmed positive test for HIV
Positive hepatitis B surface antigen (HBsAg) test, and/or positive total hepatitis B core Ab (HBcAb) test at screening.
Positive hepatitis C (HCV) Ab test result at screening
Any anticancer treatment or any investigational agent within 4 weeks (or 5 times the half-life, whichever is shorter) prior to C1D1
Prior treatment with a CEA-targeted agent or systemic radio therapy
Clareo Health | A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)