๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-06

A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC) (NCT07416552)

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (11 items).

Location: Nebraska Cancer Specialists โ€” Omaha, Nebraska

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (2 Sites)

  • Nebraska Cancer Specialists โ€” Omaha, Nebraska
  • Univ of Wisconsin-Madison โ€” Madison, Wisconsin

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—