A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC) (NCT07416552) | Clinical Trial Compass
RecruitingPhase 1
A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC)
United States180 participantsStarted 2026-09-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 antic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Serum Concentration of SPLIT Abs
Timeframe: Up to approximately 48 weeks
2
Part 1: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM
Timeframe: Up to approximately 48 weeks
3
Part 1 to 2: Absorbed Radiation Dose of 212Pb-DOTAM extrapolated from 203Pb-DOTAM
Timeframe: Up to approximately 48 weeks
4
Part 1 to 3: Percentage of Participants With Adverse Events (AE)
Timeframe: Up to approximately 5 years
Trial details
NCT IDNCT07416552
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2034-02-12
Contact for this trial
Reference Study ID Number: BP45930 https://forpatients.roche.com/ No attachments to email below.