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NCT07416552RecruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
180 (estimated)
First submitted
11 Feb 2026
Start date
13 Oct 2026
Primary completion date
12 Feb 2034
Lead sponsor
Hoffmann-La Roche
NCT number
NCT07416552
EU CT number
2025-523322-40-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 180
  • From 13 Oct 2026 to the primary completion date, 12 Feb 2034
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • History of malignancy other than the one under investigation
  • 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

Other

  • Pregnant or breastfeeding or intending to become pregnant
  • Participants with active central nervous system (CNS) metastases

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The University of Chicago Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Univ of Wisconsin-Madison
Coordinator of this site? Confirm its status
MadisonUnited StatesRecruiting
Nebraska Cancer Specialists
Coordinator of this site? Confirm its status
OmahaUnited StatesRecruiting
Washington University School of Medicine in St. Louis
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.