Precemtabart Tocentecan for Colorectal Cancer

Recruiting at 2 trial locations

Overseen By Communication Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: EMD Serono Research & Development Institute, Inc.

Disqualifiers: Brain metastases, Additional malignancy, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 19 months

1020 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluoride/tipiracil (FTD-TPI) plus bevacizumab.

Who Is on the Research Team?

Medical Responsible

Principal Investigator

EMD Serono Research & Development Institute, Inc.

Are You a Good Fit for This Trial?

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.

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)

How Is the Trial Designed?

Group I: Arm 2: Precem-TcT plus Bevacizumab Experimental Treatment 2 Interventions

Group II: Arm 1: Precemtabart tocentecan (Precem-TcT) Monotherapy Experimental Treatment 1 Intervention

Group III: Arm 3: Trifluridine/Tipiracil (FTD-TPI) plus Bevacizumab Active Control 2 Interventions

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

Merck KGaA, Darmstadt, Germany

Chief Medical Officer since 2022

MD

Belén Garijo

Merck KGaA, Darmstadt, Germany

Chief Executive Officer since 2021

MD