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

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
Hoffmann-La Roche
Study ID
NCT07416552
Phase
PHASE1
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SPLIT Abs — DRUG
    Participants will receive SPLIT Abs as part of the pretargeting regimen per the schedule described in the protocol.
  • 203Pb-DOTAM — DRUG
    Participants will receive 203Pb-DOTAM as an imaging surrogate per the schedule described in the protocol.
  • 212Pb-DOTAM — DRUG
    Participants will receive 212Pb-DOTAM as a therapeutic radioligand per the schedule described in the protocol.

Study Details

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.

Key Dates

Start date
Jun 16, 2026
Status verified
Jun 2026
Primary completion
Feb 12, 2034
Completion
Feb 12, 2034

Study Design

Enrollment
180 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 (Dosimetry)
    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.
  • Experimental: Part 2 (212Pb-DOTAM Administered Activity Escalation)
    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).
  • Experimental: Part 3 (Expansion)
    Participants will receive SPLIT Abs in combination with 212Pb-DOTAM at the RP2A identified based on results from Parts 1 and 2.

Primary Outcome Measure

Part 1: Serum Concentration of SPLIT Abs [ Time Frame: Up to approximately 48 weeks ]

Central Contacts

  • Reference Study ID Number: BP45930 https://forpatients.roche.com/
    888-662-6728 (U.S. and Canada)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (1)

FacilityCityStateZIPSite coordinators
Nebraska Cancer SpecialistsOmahaNebraska68130-

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By research site
Nebraska Cancer Specialists· Omaha, NE

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