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)
Recruiting · NCT07549412 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
34 locations listed across 9 US states.
- 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
- 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
- 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
- China Medical University Hospital - Taichung, Taiwan
- Sun Yat-sen University Cancer Center - Guangzhou, Guangdong, China
- Kyungpook National University Chilgok Hospital - Daegu, Gyeongsangnam-do, South Korea
- Kanagawa Cancer Center - Dept of Gastroenterology - Yokohama, Kanagawa, Japan
- GenesisCare North Shore (Oncology) - St Leonards, New South Wales, Australia
- University Health Network - Princess Margaret Cancer Centre - Toronto, Ontario, Canada
- Kindai University Hospital - Sakai-shi, Osaka, Japan
- Icon Cancer Centre Chermside - Chermside, Queensland, Australia
- Mater Misericordiae Ltd - PARENT - South Brisbane, Queensland, Australia
- Sichuan Cancer Hospital - Chengdu, Sichuan, China
- Flinders Medical Centre - Bedford Park, South Australia, Australia
- National Cancer Center Hospital - Chūōku, Tokyo-To, Japan
- Cancer Institute Hospital of JFCR - Kōtoku, Tokyo-To, Japan