Precemtabart Tocentecan for Colorectal Cancer
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.12345Why 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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Precemtabart Tocentecan with or without Bevacizumab or Trifluridine/Tipiracil plus Bevacizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
EMD Serono Research & Development Institute, Inc.
Lead Sponsor
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
Danny Bar-Zohar
Merck KGaA, Darmstadt, Germany
Chief Medical Officer since 2022
MD
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).
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, ...
5.
trial.medpath.com
trial.medpath.com/news/83dc051c086c6335/merck-kgaa-s-precem-tct-adc-shows-31-response-rate-in-colorectal-cancer-advances-to-phase-iiiMerck 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 ...
6.
clinicaltrialsarena.com
clinicaltrialsarena.com/news/merck-kgaa-adc-safety-tolerability-colorectal-cancer-trial/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.
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