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Metastatic Colorectal CancerPhase 1NCT07416552

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

A Phase 1 study testing SPLIT Abs, 203Pb-DOTAM and 212Pb-DOTAM in people with Metastatic Colorectal Cancer, run by Hoffmann-La Roche at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
SPLIT Abs, 203Pb-DOTAM and 212Pb-DOTAM
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
5 sitesUnited States
Study dates
13 Oct 2026to 12 Feb 2034
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

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

global-roche-genentech-trials@gene.com

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

5 sites in 1 country

United States5 sites, 5 recruiting

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637-1426

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Univ of Wisconsin-Madison

    Madison, Wisconsin, 53792

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Recruiting

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110-1010

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
SPLIT Abs, 203Pb-DOTAM, 212Pb-DOTAM
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPLIT AbsDrug

    Also called RO7782304, RO7782306

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

  • 203Pb-DOTAMDrug

    Also called RO7205834-009

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

  • 212Pb-DOTAMDrug

    Also called RO7205834-010

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

Study groups in NCT07416552
Study groupRoleWhat they receive
Part 1 (Dosimetry)ExperimentalParticipants will receive SeParated v-domains LInkage Technology Antibodies (SPLIT Abs) administered intravenously (IV). During Cycle 1, following an initial dosing interval, participants will receive 203Pb-DOTAM for imaging-based dosimetry assessment, followed by administration of 212Pb-DOTAM. In other cycles, participants will receive SPLIT Abs in combination with 212Pb-DOTAM only. Treatment will be administered every 4 weeks (Q4W) for up to 6 cycles. Each cycle is 28 days.
Receives: Drug: SPLIT Abs; Drug: 203Pb-DOTAM; Drug: 212Pb-DOTAM
Part 2 (212Pb-DOTAM Administered Activity Escalation)ExperimentalParticipants will receive SPLIT Abs at the dose and dosing interval selected in Part 1 in combination with 212Pb-DOTAM. The administered activity of 212Pb-DOTAM will be increased stepwise in each cohort to identify the maximum tolerated administered 212 activity (MTA) or a recommended Phase 2 administered activity (RP2A).
Receives: Drug: SPLIT Abs; Drug: 203Pb-DOTAM; Drug: 212Pb-DOTAM
Part 3 (Expansion)ExperimentalParticipants will receive SPLIT Abs in combination with 212Pb-DOTAM at the RP2A identified based on results from Parts 1 and 2.
Receives: Drug: SPLIT Abs; Drug: 212Pb-DOTAM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Serum Concentration of SPLIT Abs

    Measured: Up to approximately 48 weeks

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

    Measured: Up to approximately 48 weeks

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

    Measured: Up to approximately 48 weeks

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

    Measured: Up to approximately 5 years

Secondary outcomes (11)

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

    Measured: Up to approximately 48 weeks

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

    Measured: Up to approximately 48 weeks

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

    Measured: Up to approximately 48 weeks

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

    Measured: Up to approximately 48 weeks

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

    Measured: Baseline, Up to approximately 48 weeks

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

    Measured: Up to approximately 48 weeks

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

    Measured: Up to approximately 48 weeks

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

    Measured: Up to approximately 48 weeks

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

    Measured: Up to approximately 48 weeks

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

    Measured: Up to approximately 48 weeks

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

    Measured: Up to approximately 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2026
  2. Study start13 Oct 2026
  3. Primary completion12 Feb 2034 (estimated)
  4. Study completion12 Feb 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07416552
Sponsor's protocol ID
BP45930
Other IDs
2025-523322-40-00, 2025
Status last verified
Nov 2026
First submitted
11 Feb 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SPLIT Abs, 203Pb-DOTAM and 212Pb-DOTAM in people with Metastatic Colorectal Cancer, run by Hoffmann-La Roche at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: BP45930 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Serum Concentration of SPLIT Abs (time frame: Up to approximately 48 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07416552.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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