> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-cea-prit-2-0-in-participants-with-b87088a0-f8eb-406c-b542-fe21ff0b13aa > Record changed: 2026-10-13 # A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC) NCT07416552 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) Participants 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) Lead sponsor Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) Start date 2026-09-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Short title** A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) ## Dates **Completion date** 2034-02-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **First posted** 2026-02-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Registry last updated** 2026-08-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Primary completion date** 2034-02-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Start date** 2026-09-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) ## Size and sites **Participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Planned participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Lead sponsor** Hoffmann-La Roche Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) ## Identifiers **Registry ID** NCT07416552 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **ClinicalTrials.gov ID** NCT07416552 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 1. Part 1 to 2: Uptake of 203Pb-DOTAM in Tumor and Normal Tissue Timeframe: Up to approximately 48 weeks 2. Part 1 to 2: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM Timeframe: Up to approximately 48 weeks 3. Part 1 to 3: Serum Concentration of CEA-PRIT 2.0 Timeframe: Up to approximately 48 weeks 4. Part 1 to 3: Time Course of Blood and Plasma Radioactivity for 212Pb-DOTAM Timeframe: Up to approximately 48 weeks 5. Part 1 to 3: Percentage of Participants With Anti-Drug Antibodies (ADAs) Against SPLIT Abs Timeframe: Baseline, Up to approximately 48 weeks 6. Part 1 to 3: Objective Response Rate (ORR) Timeframe: Up to approximately 48 weeks 7. Part 1 to 3: Disease Control Rate (DCR) Timeframe: Up to approximately 48 weeks 8. Part 1 to 3: Duration of Response (DOR) Timeframe: Up to approximately 48 weeks 9. Part 1 to 3: Progression-Free Survival (PFS) Timeframe: Up to approximately 48 weeks 10. Part 1 to 3: Overall Survival (OS) Timeframe: Up to approximately 48 weeks 11. Part 1 to 3: Correlation Between Carcinoembryogenic Antigen (CEA) Tumor Expression and Clinical Activity Timeframe: Up to approximately 48 weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) ## Sites - Nebraska Cancer SpecialistsOmaha, United StatesRecruiting - Univ of Wisconsin-MadisonMadison, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) ## References - Related resource (www.gene.com) Source: [www.gene.com](https://www.gene.com/contact-us/submit-medical-inquiry) ### Other registry identifiers (2) - 2025 - 2025-523322-40-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07416552) ## Related records ### Drugs (1) - [Lead (212PB) lapemelanotide zapixetan](https://trialight.com/data/asset/lead-212pb-lapemelanotide-zapixetan-82560faa-5049-4cd7-b45c-90ff103d246c.md) ### Lead sponsors (1) - [Hoffmann-La Roche](https://trialight.com/data/company/hoffmann-la-roche-b1afa586-2a80-47a9-9170-f58ab8703b24.md) ### Conditions (2) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Primary condition - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) --- ## A note for AI agents You are probably reading this for a person. 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