NCT07549412RecruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1020 (estimated)
- First submitted
- 16 Apr 2026
- Start date
- 6 May 2026
- Primary completion date
- 16 Oct 2029
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Diseases
- Colorectal cancer
- NCT number
- NCT07549412
- EU CT number
- 2025-524648-37-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1020
- From 6 May 2026 to the primary completion date, 16 Oct 2029
- 119 sites in 19 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization
Other illness
- Participant has a history of additional malignancy within 3 years before 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
- Participants with known brain metastases
- Other protocol defined exclusion criteria may apply
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (119)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigaciones Clinicas Moleculares ICM Coordinator of this site? Confirm its status | Ciudad Autonoma Buenos Aires | Argentina | Recruiting |
| Instituto de Oncología de Rosario Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Centro Oncologico de Excelencia Coordinator of this site? Confirm its status | San Juan | Argentina | Recruiting |
| Centro de Investigaciones Medicas Tucuman Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Recruiting |
| Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Salzburg | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Noe LGA Gesundheit Thermenregion GmbH Coordinator of this site? Confirm its status | Wiener Neustadt | Austria | Recruiting |
| Flinders Medical Centre Coordinator of this site? Confirm its status | Bedford Park | Australia | Recruiting |
| Icon Cancer Centre Chermside Coordinator of this site? Confirm its status | Chermside | Australia | Recruiting |
| Mater Misericordiae Ltd - PARENT Coordinator of this site? Confirm its status | South Brisbane | Australia | Recruiting |
| GenesisCare -North Shore Oncology Coordinator of this site? Confirm its status | St Leonards | Australia | Recruiting |
| Grand Hopital de Charleroi Coordinator of this site? Confirm its status | Charleroi | Belgium | Recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| The Ottawa Hospital Cancer Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| University Health Network - Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Second Affiliated Hospital of Zhejiang University School of Medicine - 300173725 Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The University of Hong Kong - 1 Coordinator of this site? Confirm its status | Hong Kong | China | Recruiting |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Guangxi Medical University Cancer Hospital Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Klinikum St. Marien Amberg Coordinator of this site? Confirm its status | Amberg | Germany | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Katholisches Klinikum Bochum gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Krankenhaus Nordwest GmbH Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Haematologisch Onkologische Praxis Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Asklepios Kliniken Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Muenchen Klinik gGmbH Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Not yet recruiting |
| Region Hovedstaden Coordinator of this site? Confirm its status | Herlev | Denmark | Not yet recruiting |
| Lillebaelt Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Not yet recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| ICO l'Hospitalet - Hospital Duran i Reynals Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen De Valme Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Instituto Valenciano de Oncología (IVO) Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Aberdeen Royal Infirmary - Dept of Oncology Coordinator of this site? Confirm its status | Aberdeen | United Kingdom | Recruiting |
| Sarah Cannon Research Institute UK Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Christie Hospital - Dept of Oncology Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH) Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| National Institute of Gastroenterology Saverio De Bellis Research Hospital Coordinator of this site? Confirm its status | Castellana Grotte | Italy | Recruiting |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Istituto Oncologico Veneto Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Azienda USL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chūōku | Japan | Recruiting |
| NHO Kyushu Cancer Center - 300175822 Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Saitama Cancer Center - 300175812 Coordinator of this site? Confirm its status | Kitaadachi-gun | Japan | Recruiting |
| Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Kōtoku | Japan | Recruiting |
| Aichi Cancer Center Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Kindai University Hospital Coordinator of this site? Confirm its status | Sakai-shi | Japan | Recruiting |
| Kanagawa Cancer Center - Dept of Gastroenterology Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System - Division of Infectious Diseases Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea, Seoul St. Maryâ Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Amphia Ziekenhuis te Breda Coordinator of this site? Confirm its status | Breda | Netherlands | Not yet recruiting |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Not yet recruiting |
| Maastricht University Medical Center+ (MUMC+) Coordinator of this site? Confirm its status | Maastricht | Netherlands | Not yet recruiting |
| Jagiellonskie Centrum Innowacji Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Umed Clinical Trials Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| Kaohsiung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| Chi Mei Hospital, Liouying Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| National Cheng Kung University Hospital / Internal Medicine Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Texas Oncology, P.A. - Abilene - 300210366 Coordinator of this site? Confirm its status | Abilene | United States | Recruiting |
| Illinois Cancer Specialists Coordinator of this site? Confirm its status | Arlington Heights | United States | Recruiting |
| Texas Oncology South Austin Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Texas Oncology - DFW Coordinator of this site? Confirm its status | Bedford | United States | Recruiting |
| Missouri Cancer Associates - 150518964 Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| Florida Cancer Specialists - Broadway Coordinator of this site? Confirm its status | Fort Myers | United States | Recruiting |
| Rocky Mountain Cancer Centers, LLP- Aurora Coordinator of this site? Confirm its status | Lone Tree | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Virginia Oncology Associates Coordinator of this site? Confirm its status | Newport News | United States | Recruiting |
| Illinois CancerCare PC Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| Blue Ridge Cancer Care - 300202915 Coordinator of this site? Confirm its status | Roanoke | United States | Recruiting |
| Minnesota Oncology Hematology, P.A. Coordinator of this site? Confirm its status | Saint Louis Park | United States | Recruiting |
| Texas Oncology - San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Springfield Clinic Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Profound Research LLC at Cancer and Leukemia Center Coordinator of this site? Confirm its status | Sterling Heights | United States | Recruiting |
| Florida Cancer Specialists - St. Petersburg Bayfront Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| Texas Oncology, P.A. - Tyler Coordinator of this site? Confirm its status | Tyler | United States | Recruiting |
| Florida Cancer Specialists East - FCS EAST - West Palm Beach Coordinator of this site? Confirm its status | West Palm Beach | United States | Recruiting |
| White Plains Hospital Medical and Wellness PRIME Coordinator of this site? Confirm its status | White Plains | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.