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CEA-PRIT 2.0 for Metastatic Colorectal Cancer

This study is looking into a new treatment called CEA-PRIT 2.0 for people with metastatic colorectal cancer (mCRC). This is cancer that has spread from the colon or rectum to other parts of the body. The treatment involves three parts: SPLIT Abs, 203Pb-DOTAM, and 212Pb-DOTAM. Researchers want to understand how safe and effective CEA-PRIT 2.0 is, how the body handles it (pharmacokinetics), and how it affects the body (pharmacodynamics). You might be able to join if you have mCRC that has continued to grow despite standard treatments, and your cancer has a specific biomarker called MSS or proficient mismatch repair (MMR). The study will track how much of the SPLIT Abs is in your blood and how much radiation from 203Pb-DOTAM and 212Pb-DOTAM your body absorbs, for up to about 48 weeks.

Study design
This is an interventional study with a planned enrollment of 180 participants. The specific phase of the study is not mentioned.
What's involved
Participants will receive SPLIT Abs, 203Pb-DOTAM, and 212Pb-DOTAM according to a schedule. Researchers will measure drug levels in your blood, plasma, and urine.
Compensation
Not stated in the trial record.
Follow-up
The study will track certain measurements for up to approximately 48 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07416552

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Hoffmann-La Roche
~180 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:SPLIT Abs203Pb-DOTAM212Pb-DOTAM

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Serum Concentration of SPLIT Abs
Measured over Up to approximately 48 weeks
+3 more outcomes measured

Conditions

Metastatic Colorectal Cancer

Explore related trials

Colorectal CarcinomaMRC1 wt AlleleMSI1 Gene

Where it's being run

2 sites across 2 states
Nebraska1
Wisconsin1

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: BP45930 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. and Canada)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Part 1: Serum Concentration of SPLIT AbsUp to approximately 48 weeks
  • Part 1: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAMUp to approximately 48 weeks
  • Part 1 to 2: Absorbed Radiation Dose of 212Pb-DOTAM extrapolated from 203Pb-DOTAMUp to approximately 48 weeks
  • Part 1 to 3: Percentage of Participants With Adverse Events (AE)Up to approximately 5 years