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RECRUITING
NCT07416552
PHASE1

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-10-06

Completion Date

2034-02-12

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

DRUG

SPLIT Abs

Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.

DRUG

203Pb-DOTAM

Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.

DRUG

212Pb-DOTAM

Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.

Locations (5)

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