RecruitingMetastatic Colorectal Cancer
A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
This study will evaluate the dosimetry, safety, efficacy, pharmacokinetics (PK), pharmacodynamics and immunogenicity of CEA-PRIT 2.0 in participants with metastatic microsatellite-stable (MSS) mCRC who are intolerant to or have progressed after having received available standard-of-care (SOC) therapies.
Sponsor: Hoffmann-La Roche
You may qualify 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 qualify 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT07416552 · last updated 2026-08-10