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

NCT07416552 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-12
Primary Completion
2034-02-12
Completion
2034-02-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07416552 on ClinicalTrials.gov