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A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)

RecruitingPhase 1

A Phase I, Open-Label, Escalation and Expansion Study to Evaluate Dosimetry, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CEA-Pre-Targeted 212Pb Therapy in Participants With Metastatic Colorectal Cancer

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

About the 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.

What is being tested

Sponsor: Hoffmann-La Roche · Participants: 180 · Started: Oct 13, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07416552

Locations in the U.S.

IllinoisThe University of Chicago Medical Center, Chicago
MissouriWashington University School of Medicine in St. Louis, St Louis
NebraskaNebraska Cancer Specialists, Omaha
TexasMD Anderson Cancer Center, Houston
WisconsinUniv of Wisconsin-Madison, Madison

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.