1020 Participants NeededMy employer runs this trial

Precemtabart Tocentecan for Colorectal Cancer

Recruiting at 66 trial locations
UM
CC
Overseen ByCommunication Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: EMD Serono Research & Development Institute, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatment options for individuals with metastatic colorectal cancer (mCRC) who have already undergone some standard treatments. It tests a new drug, precemtabart tocentecan, either alone or with bevacizumab, to determine if it extends patient survival compared to a current treatment option. This trial may suit patients whose cancer has spread and who have tried several treatments but seek additional options. As a Phase 3 trial, it represents the final step before FDA approval, providing patients access to promising treatments before they become widely available.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that Precemtabart Tocentecan (Precem-TcT) had a manageable safety profile. While some side effects occurred, they were expected and not severe. The drug was tested at doses of 2.8 mg per kg, and no new or surprising problems emerged.

Research has shown that combining Precem-TcT with Bevacizumab is also safe and tolerable. This combination has not caused any unexpected side effects beyond those typical for these treatments.

It's important to note that Precem-TcT remains under study, but evidence so far suggests it is relatively safe for patients. However, like many cancer treatments, it may cause common side effects such as low blood cell counts, leading to tiredness or a higher risk of infections.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for colorectal cancer, which often include chemotherapy and targeted therapies like FTD-TPI with Bevacizumab, Precemtabart Tocentecan (Precem-TcT) offers something new. Researchers are excited about Precem-TcT because it introduces a novel mechanism of action that specifically targets tumor cells more effectively, potentially leading to better outcomes. Additionally, when combined with Bevacizumab, Precem-TcT could enhance anti-tumor activity beyond what current combinations achieve. This dual approach not only aims to improve survival rates but also offers hope for a more efficient treatment with possibly fewer side effects.

What evidence suggests that this trial's treatments could be effective for metastatic colorectal cancer?

Research has shown that Precemtabart Tocentecan (Precem-TcT) may help treat metastatic colorectal cancer (mCRC). In this trial, participants may receive Precem-TcT alone, which controlled the disease in 58.8% of patients in studies, with some experiencing partial tumor shrinkage. On average, patients lived about 6.9 months without cancer progression. Another group in this trial will receive Precem-TcT combined with bevacizumab, which increased the disease control rate to 72.4% after 12 weeks in studies. These results suggest that Precem-TcT, whether used alone or with bevacizumab, could help extend the lives of patients with mCRC.12356

Who Is on the Research Team?

MR

Medical Responsible

Principal Investigator

EMD Serono Research & Development Institute, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with metastatic colorectal cancer who have already tried up to two types of treatments that didn't work or stopped working. Participants must be able to swallow pills, feel well enough for daily activities, and meet other basic health requirements.

Inclusion Criteria

* Other protocol defined inclusion criteria may apply
I have had no more than 2 treatments for my metastatic cancer.
I have metastatic colorectal cancer that did not respond to up to 2 standard treatments.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Precemtabart Tocentecan with or without Bevacizumab or Trifluridine/Tipiracil plus Bevacizumab

19 months
Cycle 1 Day 1 and Day 1 of every new cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • Precemtabart Tocentecan
  • Trifluridine/Tipiracil (FTD-TPI)

Trial Overview

The study compares a new drug called precemtabart tocentecan (alone or with bevacizumab) against the standard treatment trifluridine/tipiracil plus bevacizumab. Patients are randomly assigned to one of these groups.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2: Precem-TcT plus BevacizumabExperimental Treatment2 Interventions
Group II: Arm 1: Precemtabart tocentecan (Precem-TcT) MonotherapyExperimental Treatment1 Intervention
Group III: Arm 3: Trifluridine/Tipiracil (FTD-TPI) plus BevacizumabActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

EMD Serono Research & Development Institute, Inc.

Lead Sponsor

Trials
86
Recruited
22,700+

Miguel Fernández Alcalde

EMD Serono Research & Development Institute, Inc.

Chief Executive Officer

Bachelor’s Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master’s Degree in Management from IESE Business School

Danny Bar-Zohar

EMD Serono Research & Development Institute, Inc.

Chief Medical Officer since 2022

MD

Merck KGaA, Darmstadt, Germany

Industry Sponsor

Trials
449
Recruited
122,000+
Danny Bar-Zohar profile image

Danny Bar-Zohar

Merck KGaA, Darmstadt, Germany

Chief Medical Officer since 2022

MD

Belén Garijo profile image

Belén Garijo

Merck KGaA, Darmstadt, Germany

Chief Executive Officer since 2021

MD

Citations

Precemtabart tocentecan, an anti-CEACAM5 antibody– ...

At doses ≥2.4 mg kg−1—the predicted clinically effective dose—the DCR was 58.8% (confirmed partial response rate, 8.8%) and the mPFS was 6.7 ...

Precemtabart tocentecan (Precem-TcT, M9140) in patients ...

The median duration of treatment was 6.5 months (min, max: 0.4, 18.6). The median progression-free survival was 6.9 months (95% CI: 4.4, 9.7).

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40739424/

Precemtabart tocentecan, an anti-CEACAM5 antibody-drug ...

Precemtabart tocentecan, an anti-CEACAM5 antibody-drug conjugate, in metastatic colorectal cancer: a phase 1 trial. Nat Med. 2025 Oct;31(10):3504-3513. doi ...

NCT07549412 | A Study of Precemtabart Tocentecan With ...

This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, ...

Merck KGaA's Precem-TcT ADC Shows 31% Response Rate ...

Merck KGaA's Precem-TcT ADC Shows 31% Response Rate in Colorectal Cancer, Advances to Phase III · Strong Efficacy Signals Drive Accelerated ...

ASCO25: Merck KGaA's ADC shows safety and tolerability ...

Merck KGaA's antibody-drug conjugate (ADC), precemtabart tocentecan, has shown to be safe and tolerable in a Phase Ib trial.