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Clinical Trials in the USA / NCT07549412
Recruiting Phase 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)

NCT07549412 · tracked via the Priya Life Science USA tracker
Sponsor
EMD Serono Research & Development Institute, Inc.
Phase
Phase 3
Started
2026-05-06
Last updated
2026-09-09

Condition(s) studied

Metastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

Precemtabart tocentecanBevacizumabTrifluridine/Tipiracil (FTD-TPI)

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (66)

FacilityCityRegionStatus
Rocky Mountain Cancer Centers, LLP- Aurora Lone Tree Colorado Recruiting
Florida Cancer Specialists-Broadway Fort Myers Florida Recruiting
Florida Cancer Specialists - St. Petersburg Bayfront St. Petersburg Florida Recruiting
Florida Cancer Specialists East - FCS EAST - West Palm Beach West Palm Beach Florida Recruiting
Illinois Cancer Specialists Arlington Heights Illinois Recruiting
Illinois CancerCare PC Peoria Illinois Recruiting
Springfield Clinic Springfield Illinois Recruiting
Profound Research LLC at Cancer and Leukemia Center Sterling Heights Michigan Recruiting
Minnesota Oncology Hematology, P.A. Saint Louis Park Minnesota Recruiting
Missouri Cancer Associates - 150518964 Columbia Missouri Recruiting
White Plains Hospital Medical and Wellness PRIME White Plains New York Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Texas Oncology, P.A. - Abilene - 300210366 Abilene Texas Recruiting
Texas Oncology-South Austin Austin Texas Recruiting
Texas Oncology DFW Bedford Texas Recruiting
Texas Oncology- San Antonio San Antonio Texas Recruiting
Texas Oncology, P.A. - Tyler Tyler Texas Recruiting
Virginia Oncology Associates Newport News Virginia Recruiting
Blue Ridge Cancer Care - 300202915 Roanoke Virginia Recruiting
Instituto de Oncologia de Rosario Rosario Santa Fe Province Recruiting
Investigaciones Clinicas Moleculares ICM Ciudad Autonoma Buenos Aires Argentina Recruiting
Centro Oncologico de Excelencia San Juan Argentina Recruiting
Centro de Investigaciones Medicas Tucuman San Miguel de Tucumán Argentina Recruiting
GenesisCare North Shore (Oncology) St Leonards New South Wales Recruiting
Icon Cancer Centre Chermside Chermside Queensland Recruiting
Mater Misericordiae Ltd - PARENT South Brisbane Queensland Recruiting
Flinders Medical Centre Bedford Park South Australia Recruiting
LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie Salzburg Austria Recruiting
Cliniques Universitaires Saint-Luc - STL Brussels Belgium Recruiting
Grand Hospital de Charleroi - PARENT Charleroi Belgium Recruiting
The Ottawa Hospital Cancer Centre Ottawa Ontario Recruiting
University Health Network - Princess Margaret Cancer Centre Toronto Ontario Recruiting
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
Guangxi Medical University Cancer Hospital Nanning Guangxi Zhuang Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei Recruiting
Jiangsu Province Hospital Nanjing Jiangsu Recruiting
Sichuan Cancer Hospital Chengdu Sichuan Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine - 300173725 Hangzhou Zhejiang Recruiting
Hopital Claude Huriez - CHU Lille - service d'oncologie medicale Lille Nord Recruiting
CHU Saint Etienne - Hôpital Nord - Service de Gastro-Entérologie et Hépatologie Saint Priest En Jarez Pays de la Loire Region Recruiting

+ 26 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07549412 on ClinicalTrials.gov ↗ ← All trials in the USA