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

Recruiting now · Phase 1

Conditions studied: Metastatic Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT07416552

Run by

Hoffmann-La Roche

People needed

180

Starts

2026-09-08

Expected to finish

2034-02-12

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
• Univ of Wisconsin-Madison — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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