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.
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
- 6 Oct 2026to 12 Feb 2034
- Phase
- Phase 1
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
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- 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
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
- 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
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.
- Conditions
- Metastatic Colorectal Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Part 1 (Dosimetry) | Experimental | Participants 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) | Experimental | Participants 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) | Experimental | Participants 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.
Part 1: Serum Concentration of SPLIT Abs
Measured: Up to approximately 48 weeks
Part 1: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM
Measured: Up to approximately 48 weeks
Part 1 to 2: Absorbed Radiation Dose of 212Pb-DOTAM extrapolated from 203Pb-DOTAM
Measured: Up to approximately 48 weeks
Part 1 to 3: Percentage of Participants With Adverse Events (AE)
Measured: Up to approximately 5 years
Secondary outcomes (11)
Part 1 to 2: Uptake of 203Pb-DOTAM in Tumor and Normal Tissue
Measured: Up to approximately 48 weeks
Part 1 to 2: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM
Measured: Up to approximately 48 weeks
Part 1 to 3: Serum Concentration of CEA-PRIT 2.0
Measured: Up to approximately 48 weeks
Part 1 to 3: Time Course of Blood and Plasma Radioactivity for 212Pb-DOTAM
Measured: Up to approximately 48 weeks
Part 1 to 3: Percentage of Participants With Anti-Drug Antibodies (ADAs) Against SPLIT Abs
Measured: Baseline, Up to approximately 48 weeks
Part 1 to 3: Objective Response Rate (ORR)
Measured: Up to approximately 48 weeks
Part 1 to 3: Disease Control Rate (DCR)
Measured: Up to approximately 48 weeks
Part 1 to 3: Duration of Response (DOR)
Measured: Up to approximately 48 weeks
Part 1 to 3: Progression-Free Survival (PFS)
Measured: Up to approximately 48 weeks
Part 1 to 3: Overall Survival (OS)
Measured: Up to approximately 48 weeks
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.
- First posted18 Feb 2026
- Study start6 Oct 2026 (estimated)
- Primary completion12 Feb 2034 (estimated)
- Study completion12 Feb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416552
- Sponsor's protocol ID
- BP45930
- Other IDs
- 2025-523322-40-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 11 Feb 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No