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NCT07416552PHASE1Recruiting

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

Hoffmann-La Roche

Start Date

10/6/2026

Completion Date

2/12/2034

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

SPLIT Abs

DRUG

203Pb-DOTAM

DRUG

212Pb-DOTAM

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Conditions

Metastatic Colorectal Cancer

Locations

The University of Chicago Medical Center

Chicago, Illinois 60637-1426

United States

Washington University School of Medicine in St. Louis

St Louis, Missouri 63110-1010

United States

Nebraska Cancer Specialists

Omaha, Nebraska 68130

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Univ of Wisconsin-Madison

Madison, Wisconsin 53792

United States