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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT07416552

Registry updated: 2026-10-06
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Description

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.

Interventions

  • SPLIT Abs (Drug)
    Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
  • 203Pb-DOTAM (Drug)
    Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.
  • 212Pb-DOTAM (Drug)
    Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.

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

Conditions

Metastatic Colorectal Cancer

Locations

  • The University of Chicago Medical Center — Chicago, Illinois, United States
  • Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
  • Nebraska Cancer Specialists — Omaha, Nebraska, United States
  • MD Anderson Cancer Center — Houston, Texas, United States
  • Univ of Wisconsin-Madison — Madison, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record