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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
2026-03-31
Completion Date
2034-02-12
Last Updated
2026-03-16
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.