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NCT Number: NCT07416552

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPLIT Abs

Drug

Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.

Other names: RO7782304, RO7782306

203Pb-DOTAM

Drug

Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.

Other names: RO7205834-009

212Pb-DOTAM

Drug

Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.

Other names: RO7205834-010

Primary outcomes

  1. Part 1: Serum Concentration of SPLIT Abs

    Time frame: Up to approximately 48 weeks

  2. Part 1: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM

    Time frame: Up to approximately 48 weeks

  3. Part 1 to 2: Absorbed Radiation Dose of 212Pb-DOTAM extrapolated from 203Pb-DOTAM

    Time frame: Up to approximately 48 weeks

  4. Part 1 to 3: Percentage of Participants With Adverse Events (AE)

    Time frame: Up to approximately 5 years

Secondary outcomes

  1. Part 1 to 2: Uptake of 203Pb-DOTAM in Tumor and Normal Tissue

    Time frame: Up to approximately 48 weeks

  2. Part 1 to 2: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM

    Time frame: Up to approximately 48 weeks

  3. Part 1 to 3: Serum Concentration of CEA-PRIT 2.0

    Time frame: Up to approximately 48 weeks

  4. Part 1 to 3: Time Course of Blood and Plasma Radioactivity for 212Pb-DOTAM

    Time frame: Up to approximately 48 weeks

  5. Part 1 to 3: Percentage of Participants With Anti-Drug Antibodies (ADAs) Against SPLIT Abs

    Time frame: Baseline, Up to approximately 48 weeks

  6. Part 1 to 3: Objective Response Rate (ORR)

    Time frame: Up to approximately 48 weeks

  7. Part 1 to 3: Disease Control Rate (DCR)

    Time frame: Up to approximately 48 weeks

  8. Part 1 to 3: Duration of Response (DOR)

    Time frame: Up to approximately 48 weeks

  9. Part 1 to 3: Progression-Free Survival (PFS)

    Time frame: Up to approximately 48 weeks

  10. Part 1 to 3: Overall Survival (OS)

    Time frame: Up to approximately 48 weeks

  11. Part 1 to 3: Correlation Between Carcinoembryogenic Antigen (CEA) Tumor Expression and Clinical Activity

    Time frame: Up to approximately 48 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: BP45930 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. and Canada)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
Feb 18, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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