RecruitingPhase 3NCT07549412

A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)


Sponsor

EMD Serono Research & Development Institute, Inc.

Enrollment

1,020 participants

Start Date

May 6, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bevacizumab, a drug called Precemtabart tocentecan, and others for people with metastatic colorectal cancer. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPrecemtabart tocentecan

Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.

DRUGBevacizumab

Bevacizumab, administered intravenously every 3 weeks on Day 1 of each 21-day cycle or every 2 weeks on Day 1 and Day 15 of each 28-day cycle.

DRUGTrifluridine/Tipiracil (FTD-TPI)

FTD-TPI, tablet, administered orally twice daily, on Days 1 to 5 and Days 8 to 12 of each 28-day cycle.


Locations(21)

Rocky Mountain Cancer Centers, LLP- Aurora

Lone Tree, Colorado, United States

Illinois Cancer Specialists

Arlington Heights, Illinois, United States

Illinois CancerCare PC

Peoria, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Profound Research LLC at Cancer and Leukemia Center

Sterling Heights, Michigan, United States

Minnesota Oncology Hematology, P.A.

Saint Louis Park, Minnesota, United States

Missouri Cancer Associates - 150518964

Columbia, Missouri, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Texas Oncology, P.A. - Abilene - 300210366

Abilene, Texas, United States

Texas Oncology-South Austin

Austin, Texas, United States

Texas Oncology DFW

Bedford, Texas, United States

Texas Oncology- San Antonio

San Antonio, Texas, United States

Texas Oncology, P.A. - Tyler

Tyler, Texas, United States

Virginia Oncology Associates

Newport News, Virginia, United States

Blue Ridge Cancer Care - 300202915

Roanoke, Virginia, United States

GenesisCare North Shore (Oncology)

St Leonards, New South Wales, Australia

Icon Cancer Centre Chermside

Chermside, Queensland, Australia

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

National Cancer Center Hospital

Chūōku, Tokyo-To, Japan

Samsung Medical Center

Seoul, South Korea

China Medical University Hospital

Taichung, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07549412


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