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Metastatic Colorectal CancerCancerDrugPhase 1

What this study is

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.

What's being tested

  • SPLIT Abs

    Intervention · DRUG

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

  • 203Pb-DOTAM

    Intervention · DRUG

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

  • 212Pb-DOTAM

    Intervention · DRUG

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

Study details

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
Sponsor
Hoffmann-La Roche
Conditions
Metastatic Colorectal Cancer
Enrolling
180 people
Starts
2026-10-13
Est. completion
2034-02-12
Design
Open-label, non-randomized, sequential groups, Phase 1
Record
View on ClinicalTrials.gov ↗