180 Participants NeededMy employer runs this trial

CEA-PRIT 2.0 for Colorectal Cancer

Recruiting at 2 trial locations
RS
Fr
RS
Fr
Overseen ByFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Hoffmann-La Roche
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CEA-PRIT 2.0, a targeted therapy for individuals with colorectal cancer that has metastasized and not responded to standard treatments. The study aims to determine the safety, effectiveness, and behavior of this treatment in the body. Participants will receive varying doses to identify the most effective one. This trial may suit those with metastatic colorectal cancer, previous unsuccessful treatments, and a specific tumor type known as microsatellite-stable (MSS). As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have had any anticancer treatment or investigational agent within 4 weeks before starting the trial.

Is there any evidence suggesting that CEA-PRIT 2.0 is likely to be safe for humans?

Earlier studies found CEA-PRIT 2.0 to be safe. The treatment slowed tumor growth and caused only mild, temporary weight loss in participants. Importantly, it effectively targeted tumors while limiting effects on healthy tissues. These findings suggest that CEA-PRIT 2.0 is well-tolerated, with few reported side effects.12345

Why do researchers think this study treatment might be promising?

CEA-PRIT 2.0 is unique because it targets colorectal cancer with a novel approach involving radioimmunotherapy. Unlike standard treatments like chemotherapy and targeted therapies, CEA-PRIT 2.0 uses SeParated v-domains LInkage Technology Antibodies (SPLIT Abs) combined with 212Pb-DOTAM, a radioactive substance that delivers targeted radiation directly to cancer cells. This method not only aims to improve accuracy in attacking cancer cells but also minimizes damage to healthy tissue. Researchers are excited about its potential to enhance treatment effectiveness and reduce side effects compared to conventional therapies.

What evidence suggests that CEA-PRIT 2.0 might be an effective treatment for colorectal cancer?

Research has shown that CEA-PRIT 2.0 could effectively treat colorectal cancer. In this trial, participants will receive CEA-PRIT 2.0, which combines antibodies and radioactive substances to target cancer cells, focusing treatment on tumors and minimizing harm to healthy tissue. Studies have found that this treatment can slow tumor growth with only mild side effects, such as temporary weight loss. Early results suggest this method strongly inhibits tumor growth and is safe. Tests in mice also showed positive outcomes, with the treatment effectively targeting tumors and causing limited side effects.13456

Who Is on the Research Team?

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for adults with metastatic colorectal cancer (cancer that has spread) whose tumors are microsatellite-stable and who have not responded to or cannot tolerate standard treatments. Participants must be in generally good health, have measurable disease, and a life expectancy of at least 12 weeks.

Inclusion Criteria

My heart, blood, and kidney functions are normal.
* Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
My cancer got worse during or soon after my last treatment for metastatic disease.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dosimetry

Participants receive SPLIT Abs and 203Pb-DOTAM for imaging-based dosimetry assessment, followed by 212Pb-DOTAM administration

4 weeks
1 visit (in-person) per cycle

Treatment

Participants receive SPLIT Abs in combination with 212Pb-DOTAM every 4 weeks for up to 6 cycles

24 weeks
1 visit (in-person) per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CEA-PRIT 2.0

Trial Overview

The study is testing CEA-PRIT 2.0, which uses special antibodies (SPLIT Abs) combined with radioactive substances (212Pb-DOTAM and 203Pb-DOTAM) to target cancer cells. The goal is to see how safe and effective this new treatment approach is.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Part 3 (Expansion)Experimental Treatment2 Interventions
Group II: Part 2 (212Pb-DOTAM Administered Activity Escalation)Experimental Treatment3 Interventions
Group III: Part 1 (Dosimetry)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

SPLIT PRIT: A Novel Clearing Agent-Independent ...

Both CEA-PRIT regimens achieved significant and comparable tumour growth delay. Only mild transient body weight loss was observed in both groups, confirming ...

CEA-PRIT 2.0 for Colorectal Cancer

This study will evaluate the dosimetry, safety, efficacy, pharmacokinetics (PK), pharmacodynamics and immunogenicity of CEA-PRIT 2.0 in participants with ...

A Study to Investigate CEA-PRIT 2.0 in Participants ...

This study will evaluate the dosimetry, safety, efficacy, pharmacokinetics (PK), pharmacodynamics and immunogenicity of CEA-PRIT 2.0 in ...

Pretargeting: A Path Forward for Radioimmunotherapy - PMC

Pretargeted radioimmunodiagnosis and radioimmunotherapy aim to efficiently combine antitumor antibodies and medicinal radioisotopes for high-contrast imaging.

Abstract 7203: 212Pb-based CEA pretargeted ...

Conclusions CEA-PRIT 2.0 showed favorable tumor-to-healthy tissue radiation exposure and potent TGI with a favorable toxicity profile. A FIH ...

Abstract 7203: 212 Pb-based CEA pretargeted ...

Here, we report key preclinical data informing a planned first-in-human (FIH) CEA-PRIT 2.0 study in metastatic colorectal cancer (mCRC) patients ...