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NOT YET 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

2026-03-31

Completion Date

2034-02-12

Last Updated

2026-03-16

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.