NCT07416552

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-21
• Primary completion: 2034-02-12
• Completion: 2034-02-12
• First posted: 2026-02-18
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study