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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)
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- Precemtabart tocentecan (drug)
- Bevacizumab (drug)
- Trifluridine/Tipiracil (FTD-TPI) (drug)
Sponsor: EMD Serono Research & Development Institute, Inc. · Participants: 1,020 · Started: May 6, 2026
Contact the study team
- US Medical Information · Phone: 888-275-7376
- Communication Center · Phone: +49 6151 72 5200
Official record on ClinicalTrials.gov — NCT07549412
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.