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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 trifluridine/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

Florida Cancer Specialists-Broadway

Fort Myers, Florida 33901

United States

Florida Cancer Specialists - St. Petersburg Bayfront

St. Petersburg, Florida 33701-4553

United States

Florida Cancer Specialists East - FCS EAST - West Palm Beach

West Palm Beach, Florida 33401

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

White Plains Hospital Medical and Wellness PRIME

White Plains, New York 10601

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

Instituto de Oncologia de Rosario

Rosario, Santa Fe Province S2000KZE

Argentina

Investigaciones Clinicas Moleculares ICM

Ciudad Autonoma Buenos Aires, C1417DTB

Argentina

Centro Oncologico de Excelencia

San Juan, 5400

Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, T4000AXL

Argentina

GenesisCare North Shore (Oncology)

St Leonards, New South Wales 2065

Australia

Icon Cancer Centre Chermside

Chermside, Queensland 4032

Australia

Mater Misericordiae Ltd - PARENT

South Brisbane, Queensland 4101

Australia

Flinders Medical Centre

Bedford Park, South Australia 5042

Australia

LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie

Salzburg, 5020

Austria

Cliniques Universitaires Saint-Luc - STL

Brussels, 1200

Belgium

Grand Hospital de Charleroi - PARENT

Charleroi, 6000

Belgium

UZA - Account 3

Edegem, 2650

Belgium

UZ Leuven

Leuven, 03000

Belgium

The Ottawa Hospital Cancer Centre

Ottawa, Ontario K1H 8L6

Canada

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

Peking Union Medical College Hospital

Beijing, Beijing Municipality 100142

China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong 510060

China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi Zhuang 530021

China

The University of Hong Kong - 1

Hong Kong, Hong Kong 00000

China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei 430060

China

Jiangsu Province Hospital

Nanjing, Jiangsu 210029

China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality 201321

China

Sichuan Cancer Hospital

Chengdu, Sichuan 610041

China

The Second Affiliated Hospital of Zhejiang University School of Medicine - 300173725

Hangzhou, Zhejiang 310000

China

Institut Bergonié - Service d'Oncologie Médicale

Bordeaux, Gironde 33076

France

Hopital Claude Huriez - CHU Lille - service d'oncologie medicale

Lille, Nord 59037

France

CHU Saint Etienne - Hôpital Nord - Service de Gastro-Entérologie et Hépatologie

Saint Priest En Jarez, Pays de la Loire Region 42270

France

Centre Leon Berard - Service d'Oncologie Medicale

Lyon, Rhone 69008

France

Institut Gustave Roussy - Pathologies Digestives

Villejuif, Val De Marne 94805

France

Groupe Hospitalier Pitie-Salpetriere - Service Hépato-Gastro-Entérologie

Paris, 75013

France

Krankenhaus Nordwest GmbH - Neurologische Klinik

Frankfurt am Main, Hesse 60488

Germany

Universitaetsklinikum Leipzig AoeR - Universitaeres Krebszentrum Leipzig (UCCL)

Leipzig, Saxony 04103

Germany

Haematologisch-Onkologische Praxis Eppendorf (HOPE)

Hamburg, 20249

Germany

The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH)

Hong Kong, 00000

Hong Kong

IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica

San Giovanni Rotondo, Foggia 71013

Italy

Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento di Oncologia

Naples, 80131

Italy

Istituto Nazionale Tumori Fondazione G. Pascale - Dipartimento Oncoematologia

Naples, 80131

Italy

Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II

Pisa, 56126

Italy

Aichi Cancer Center Hospital

Nagoya, Aichi-ken 464-8681

Japan

NHO Kyushu Cancer Center - 300175822

Fukuoka, Fukuoka 811-1395

Japan

Kanagawa Cancer Center - Dept of Gastroenterology

Yokohama, Kanagawa 241-8515

Japan

Kindai University Hospital

Sakai-shi, Osaka 590-0197

Japan

Saitama Cancer Center - 300175812

Kitaadachi-gun, Saitama 362-0806

Japan

National Cancer Center Hospital

Chūōku, Tokyo-To 104-0045

Japan

Cancer Institute Hospital of JFCR

Kōtoku, Tokyo-To 135-8550

Japan

Osaka International Cancer Institute

Osaka, 541-8567

Japan

Amphia Ziekenhuis, Molengracht - Parent

Utrecht, 3584 CX

Netherlands

Wojewodzkie Centrum Onkologii

Gdansk, 80-219

Poland

SP ZOZ Szpital Uniwersytecki w Krakowie - Dept of Clinical Oncology and Oncology Clinic

Krakow, 31-501

Poland

National Cancer Center

Goyang-si, Gyeonggi-do 10408

South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

Kyungpook National University Chilgok Hospital

Daegu, Gyeongsangnam-do 700-721

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System - Division of Infectious Diseases

Seoul, 03722

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

The Catholic University of Korea, Seoul St. Maryâ

Seoul, 06591

South Korea

Korea University Guro Hospital

Seoul, 08308

South Korea

Asan Medical Center

Seoul, 138-736

South Korea

Hospital Universitario Reina Sofia - Dept of Oncology

Córdoba, Córdoba 14004

Spain

Hospital Universitari Vall d'Hebron - Oncology Dept.

Barcelona, 08035

Spain

Hospital Clinic de Barcelona - Servicio de Oncologia

Barcelona, 08036

Spain

Hospital Universitario Ramon y Cajal - Servicio de Oncologia

Madrid, 28034

Spain

Hospital Universitario Nuestra Señora de Valme

Seville, 41014

Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807

Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833

Taiwan

China Medical University Hospital

Taichung, 40447

Taiwan

National Cheng Kung University Hospital - Internal Medicine

Tainan, 70403

Taiwan

Chi Mei Hospital, Liouying

Tainan, 736

Taiwan

National Taiwan University Hospital

Taipei, 100225

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Aberdeen Royal Infirmary - Dept of Oncology

Aberdeen, Grampian Region AB25 2ZN

United Kingdom

The Christie Hospital - Dept of Oncology

Manchester, Great Manchester M20 4BX

United Kingdom

Sarah Cannon Research Institute UK

London, Greater London W1G 6AD

United Kingdom