Recruiting
Phase 1

CEA-PRIT 2.0

Sponsor:

Hoffmann-La Roche

Code:

NCT07416552

Conditions

Metastatic Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SPLIT Abs

203Pb-DOTAM

212Pb-DOTAM

Study Details

Brief 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.

Conditions

Metastatic Colorectal Cancer

Study ID

NCT07416552

Start date

Sep 8, 2026

Status verified date

Sep, 2026

Completion date

Feb 12, 2034

Anticipated

Primary completion date

Feb 12, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

SPLIT Abs

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

203Pb-DOTAM

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

212Pb-DOTAM

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

Primary outcome measure

  • Part 1: Serum Concentration of SPLIT Abs [ Time Frame: Up to approximately 48 weeks ]
  • Part 1: Time Course of Blood, Plasma, and Urine Radioactivity for 203Pb-DOTAM [ Time Frame: Up to approximately 48 weeks ]
  • Part 1 to 2: Absorbed Radiation Dose of 212Pb-DOTAM extrapolated from 203Pb-DOTAM [ Time Frame: Up to approximately 48 weeks ]
  • Part 1 to 3: Percentage of Participants With Adverse Events (AE) [ Time Frame: Up to approximately 5 years ]

Central Contacts and Locations

Central contacts

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

Locations

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Univ of Wisconsin-Madison

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-09-04.