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RECRUITING Phase 3 ClinicalTrials.gov

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)

Sponsor: EMD Serono Research & Development Institute, Inc. • ClinicalTrials.gov ID: NCT07549412

Registry updated: 2026-10-08
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Description

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.

Interventions

  • Precemtabart tocentecan (Drug)
    Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.
  • Bevacizumab (Drug)
    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.
  • Trifluridine/Tipiracil (FTD-TPI) (Drug)
    FTD-TPI, tablet, administered orally twice daily, on Days 1 to 5 and Days 8 to 12 of each 28-day cycle.

Eligibility criteria

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

Conditions

Metastatic Colorectal Cancer

Locations

  • Rocky Mountain Cancer Centers, LLP- Aurora — Lone Tree, Colorado, United States
  • Florida Cancer Specialists-Broadway — Fort Myers, Florida, United States
  • Florida Cancer Specialists - St. Petersburg Bayfront — St. Petersburg, Florida, United States
  • Florida Cancer Specialists East - FCS EAST - West Palm Beach — West Palm Beach, Florida, 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
  • White Plains Hospital Medical and Wellness PRIME — White Plains, New York, 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
  • Instituto de Oncologia de Rosario — Rosario, Santa Fe Province, Argentina
  • Investigaciones Clinicas Moleculares ICM — Ciudad Autonoma Buenos Aires, Argentina
  • Centro Oncologico de Excelencia — San Juan, Argentina
  • Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán, Argentina
  • GenesisCare North Shore (Oncology) — St Leonards, New South Wales, Australia
  • Icon Cancer Centre Chermside — Chermside, Queensland, Australia
  • Mater Misericordiae Ltd - PARENT — South Brisbane, Queensland, Australia
  • Flinders Medical Centre — Bedford Park, South Australia, Australia
  • LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie — Salzburg, Austria
  • Cliniques Universitaires Saint-Luc - STL — Brussels, Belgium
  • Grand Hospital de Charleroi - PARENT — Charleroi, Belgium
  • UZA - Account 3 — Edegem, Belgium
  • UZ Leuven — Leuven, Belgium
  • The Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada
  • University Health Network - Princess Margaret Cancer Centre — Toronto, Ontario, Canada
  • Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
  • Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
  • Guangxi Medical University Cancer Hospital — Nanning, Guangxi Zhuang, China
  • The University of Hong Kong - 1 — Hong Kong, Hong Kong, China
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China
  • Jiangsu Province Hospital — Nanjing, Jiangsu, China
  • Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China
  • Sichuan Cancer Hospital — Chengdu, Sichuan, China
  • The Second Affiliated Hospital of Zhejiang University School of Medicine - 300173725 — Hangzhou, Zhejiang, China
  • Institut Bergonié - Service d'Oncologie Médicale — Bordeaux, Gironde, France
  • Hopital Claude Huriez - CHU Lille - service d'oncologie medicale — Lille, Nord, France
  • CHU Saint Etienne - Hôpital Nord - Service de Gastro-Entérologie et Hépatologie — Saint Priest En Jarez, Pays de la Loire Region, France
  • Centre Leon Berard - Service d'Oncologie Medicale — Lyon, Rhone, France
  • Institut Gustave Roussy - Pathologies Digestives — Villejuif, Val De Marne, France
  • Groupe Hospitalier Pitie-Salpetriere - Service Hépato-Gastro-Entérologie — Paris, France
  • Krankenhaus Nordwest GmbH - Neurologische Klinik — Frankfurt am Main, Hesse, Germany
  • Universitaetsklinikum Leipzig AoeR - Universitaeres Krebszentrum Leipzig (UCCL) — Leipzig, Saxony, Germany
  • Haematologisch-Onkologische Praxis Eppendorf (HOPE) — Hamburg, Germany
  • The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH) — Hong Kong, Hong Kong
  • IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica — San Giovanni Rotondo, Foggia, Italy
  • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento di Oncologia — Naples, Italy
  • Istituto Nazionale Tumori Fondazione G. Pascale - Dipartimento Oncoematologia — Naples, Italy
  • Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II — Pisa, Italy
  • Aichi Cancer Center Hospital — Nagoya, Aichi-ken, Japan
  • NHO Kyushu Cancer Center - 300175822 — Fukuoka, Fukuoka, Japan
  • Kanagawa Cancer Center - Dept of Gastroenterology — Yokohama, Kanagawa, Japan
  • Kindai University Hospital — Sakai-shi, Osaka, Japan
  • Saitama Cancer Center - 300175812 — Kitaadachi-gun, Saitama, Japan
  • National Cancer Center Hospital — Chūōku, Tokyo-To, Japan
  • Cancer Institute Hospital of JFCR — Kōtoku, Tokyo-To, Japan
  • Osaka International Cancer Institute — Osaka, Japan
  • Amphia Ziekenhuis, Molengracht - Parent — Utrecht, Netherlands
  • Wojewodzkie Centrum Onkologii — Gdansk, Poland
  • SP ZOZ Szpital Uniwersytecki w Krakowie - Dept of Clinical Oncology and Oncology Clinic — Krakow, Poland
  • National Cancer Center — Goyang-si, Gyeonggi-do, South Korea
  • Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
  • Kyungpook National University Chilgok Hospital — Daegu, Gyeongsangnam-do, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • Severance Hospital, Yonsei University Health System - Division of Infectious Diseases — Seoul, South Korea
  • Samsung Medical Center — Seoul, South Korea
  • The Catholic University of Korea, Seoul St. Maryâ — Seoul, South Korea
  • Korea University Guro Hospital — Seoul, South Korea
  • Asan Medical Center — Seoul, South Korea
  • Hospital Universitario Reina Sofia - Dept of Oncology — Córdoba, Córdoba, Spain
  • Hospital Universitari Vall d'Hebron - Oncology Dept. — Barcelona, Spain
  • Hospital Clinic de Barcelona - Servicio de Oncologia — Barcelona, Spain
  • Hospital Universitario Ramon y Cajal - Servicio de Oncologia — Madrid, Spain
  • Hospital Universitario Nuestra Señora de Valme — Seville, Spain
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
  • Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
  • China Medical University Hospital — Taichung, Taiwan
  • National Cheng Kung University Hospital - Internal Medicine — Tainan, Taiwan
  • Chi Mei Hospital, Liouying — Tainan, Taiwan
  • National Taiwan University Hospital — Taipei, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
  • Aberdeen Royal Infirmary - Dept of Oncology — Aberdeen, Grampian Region, United Kingdom
  • The Christie Hospital - Dept of Oncology — Manchester, Great Manchester, United Kingdom
  • Sarah Cannon Research Institute UK — London, Greater London, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record