CEA-PRIT 2.0 for metastatic colorectal cancer
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
Run by Hoffmann-La Roche · NCT07416552 · Data updated 2026-11-12
This trial will test CEA-PRIT 2.0, a targeted pretargeted radioligand treatment using split antibodies and lead-based payloads, in people with metastatic microsatellite-stable colorectal cancer who have progressed on or cannot tolerate standard therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Chicago, Illinois and 4 other locations) |
| Status | Recruiting |
| Started | October 13, 2026 |
| Main results expected | February 12, 2034 |
| Study ends | February 12, 2034 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07416552 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically confirmed metastatic colorectal adenocarcinoma that is microsatellite-stable, with measurable disease, ECOG 0–1, adequate organ function, and who have progressed on or cannot tolerate available standard systemic therapies.
✕Probably not a fit
Patients who are pregnant or breastfeeding, have active central nervous system metastases, a recent other malignancy, or unresolved toxicities from prior treatments are excluded and are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
CEA-PRIT 2.0 is a Phase 1, single-site trial testing a pretargeted radioimmunotherapy approach in patients with metastatic microsatellite-stable colorectal cancer who have progressed on or are intolerant to standard treatments. The regimen uses split antibodies combined with radiolabeled payloads (203Pb-DOTAM for imaging/dosimetry and 212Pb-DOTAM for therapeutic radiation) to deliver radiation selectively to CEA-expressing tumors. Primary focus is on dosimetry and safety, with secondary endpoints including preliminary efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity. Eligible participants must have measurable disease, ECOG 0–1, adequate organ and laboratory function, and no active CNS metastases or unresolved toxicities from prior therapy.
Why it matters
Potential benefit: If successful, this approach could offer a new targeted way to deliver radiation to CEA-positive colorectal metastases and potentially shrink tumors with fewer systemic side effects.
How similar studies have gone: Related pretargeted radioimmunotherapy strategies and Pb-212 radioligands have shown early promise in small Phase 1 studies in other cancers, but CEA-directed PRIT in MSS metastatic colorectal cancer is a relatively new approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed adenocarcinoma originating from the colon or rectum * Metastatic disease (Stage IV American Joint Committee on Cancer, Version 7) * Confirmed MSS and/or proficient mismatch repair (MMR) status * Experienced disease progression during or within 3 months following the last administration of systemic anti-cancer therapies for metastatic disease * Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Life expectancy estimated by the Investigator to be \>=12 weeks * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 * Adequate cardiovascular, hematological and renal function and laboratory parameters Exclusion Criteria: * Pregnant or breastfeeding or intending to become pregnant * Participants with active central nervous system (CNS) metastases * History of malignancy other than the one under investigation * Any unresolved toxicities from prior therapy, i.e., radiotherapy, chemotherapy, targeted therapy or surgical procedure * Major surgery or significant traumatic injury \<4 weeks prior to the first CEA-PRIT 2.0 administration (excluding biopsies) or anticipation of the need for major surgery during study treatment * Participants have a known confirmed positive test for HIV * Positive hepatitis B surface antigen (HBsAg) test, and/or positive total hepatitis B core Ab (HBcAb) test at screening. * Positive hepatitis C (HCV) Ab test result at screening * Any anticancer treatment or any investigational agent within 4 weeks (or 5 times the half-life, whichever is shorter) prior to C1D1 * Prior treatment with a CEA-targeted agent or systemic radio therapy
Where it's running
-
The University of Chicago Medical Center
Chicago, Illinois, United States Recruiting -
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States Recruiting -
Nebraska Cancer Specialists
Omaha, Nebraska, United States Recruiting -
MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
Univ of Wisconsin-Madison
Madison, Wisconsin, United States Recruiting
Study contacts
- Study coordinator: Reference Study ID Number: BP45930 https://forpatients.roche.com/ No attachments to email below.
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.