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 now · Phase 3
Conditions studied: Metastatic Colorectal Cancer
In brief
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.
Key facts
- Study ID
- NCT07549412
- Run by
- EMD Serono Research & Development Institute, Inc.
- People needed
- 1020
- Starts
- 2026-05-06
- Expected to finish
- 2029-10-16
- Last updated by the study team
- 2026-07-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Rocky Mountain Cancer Centers, LLP- Aurora — Lone Tree, Colorado, United States (enrolling)
- Illinois Cancer Specialists — Arlington Heights, Illinois, United States (enrolling)
- Illinois CancerCare PC — Peoria, Illinois, United States (enrolling)
- Springfield Clinic — Springfield, Illinois, United States (enrolling)
- Profound Research LLC at Cancer and Leukemia Center — Sterling Heights, Michigan, United States (enrolling)
- Minnesota Oncology Hematology, P.A. — Saint Louis Park, Minnesota, United States (enrolling)
- Missouri Cancer Associates - 150518964 — Columbia, Missouri, United States (enrolling)
- SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
- Texas Oncology, P.A. - Abilene - 300210366 — Abilene, Texas, United States (enrolling)
- Texas Oncology-South Austin — Austin, Texas, United States (enrolling)
- Texas Oncology DFW — Bedford, Texas, United States (enrolling)
- Texas Oncology- San Antonio — San Antonio, Texas, United States (enrolling)
- Texas Oncology, P.A. - Tyler — Tyler, Texas, United States (enrolling)
- Virginia Oncology Associates — Newport News, Virginia, United States (enrolling)
- Blue Ridge Cancer Care - 300202915 — Roanoke, Virginia, United States (enrolling)
- GenesisCare North Shore (Oncology) — St Leonards, New South Wales, Australia (enrolling)
- Icon Cancer Centre Chermside — Chermside, Queensland, Australia (enrolling)
- University Health Network - Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
- National Cancer Center Hospital — Chūōku, Tokyo-To, Japan (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- China Medical University Hospital — Taichung, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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