CEA-PRIT 2.0 for metastatic colorectal cancer
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
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 |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT07416552 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Omaha, Nebraska
- Nebraska Cancer Specialists — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: BP45930 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.