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A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)
Sponsor: Hoffmann-La Roche
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
Conditions
Interventions
SPLIT Abs
Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
203Pb-DOTAM
Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.
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