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NCT07549412PHASE3Recruiting

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)

EMD Serono Research & Development Institute, Inc.

Start Date

5/6/2026

Completion Date

10/16/2029

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting. * Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting * Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1 * Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations * Other protocol defined inclusion criteria may apply Exclusion Criteria: * If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0 * Participant has a history of additional malignancy within 3 years before randomization * Participants with known brain metastases * Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization * Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments * Other protocol defined exclusion criteria may apply

Interventions

DRUG

Precemtabart tocentecan

DRUG

Bevacizumab

DRUG

Trifluridine/Tipiracil (FTD-TPI)

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Conditions

Metastatic Colorectal Cancer

Locations

Rocky Mountain Cancer Centers, LLP- Aurora

Lone Tree, Colorado 80124

United States

Illinois Cancer Specialists

Arlington Heights, Illinois 60005

United States

Illinois CancerCare PC

Peoria, Illinois 61615-7822

United States

Springfield Clinic

Springfield, Illinois 62702

United States

Profound Research LLC at Cancer and Leukemia Center

Sterling Heights, Michigan 48098

United States

Minnesota Oncology Hematology, P.A.

Saint Louis Park, Minnesota 55416

United States

Missouri Cancer Associates - 150518964

Columbia, Missouri 65201

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Texas Oncology, P.A. - Abilene - 300210366

Abilene, Texas 79606

United States

Texas Oncology-South Austin

Austin, Texas 78745

United States

Texas Oncology DFW

Bedford, Texas 75246

United States

Texas Oncology- San Antonio

San Antonio, Texas 78240

United States

Texas Oncology, P.A. - Tyler

Tyler, Texas 75702

United States

Virginia Oncology Associates

Newport News, Virginia 23606

United States

Blue Ridge Cancer Care - 300202915

Roanoke, Virginia 24014-2419

United States

GenesisCare North Shore (Oncology)

St Leonards, New South Wales 2065

Australia

Icon Cancer Centre Chermside

Chermside, Queensland 4032

Australia

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

National Cancer Center Hospital

Chūōku, Tokyo-To 104-0045

Japan

Samsung Medical Center

Seoul, 06351

South Korea

China Medical University Hospital

Taichung, 40447

Taiwan