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 Study of Precemtabart Tocentecan for Metastatic Colorectal Cancer", "This study is for people with metastatic colorectal cancer (cancer that has spread) who have already received certain standard treatments. It aims to see if a new treatment, Precemtabart tocentecan (Precem-TcT), either alone or with Bevacizumab, can help people live longer compared to a standard treatment called Trifluridine/Tipiracil plus Bevacizumab. You could be eligible if you are 18 or older, have metastatic colorectal cancer, and your cancer has not responded to or has progressed after up to two previous systemic treatments. The study is looking to enroll 1020 participants, but its current status is unclear.", "design": "This is an interventional study planning to enroll 1020 participants. It compares different treatment approaches for metastatic colorectal cancer.", "commitments": "Precemtabart tocentecan and Bevacizumab are given intravenously (into a vein) every 2 or 3 weeks. Trifluridine/Tipiracil is taken orally (by mouth) twice daily for specific days each month.", "compensation": "Not stated in the trial record.", "follow_up": "Overall survival will be measured, with assessments continuing for approximately 19 months after randomization.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT07549412

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
PHASE3Ages 18+InterventionalTreatment
EMD Serono Research & Development Institute, Inc.
~1,020 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Precemtabart tocentecanBevacizumabTrifluridine/Tipiracil (FTD-TPI)

At a glance

Recruiting sites
34 of 34 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Arm 1, 2 and 3: Overall Survival
Measured over Time from date of randomization to death, assessed approximately up to average of 19 months
Metastatic Colorectal Cancer
34 sites across 21 states
Texas5
Florida3
Illinois3
South Korea3
Virginia2
Queensland2
Tokyo-To2
Colorado1
  • Medical Responsible · STUDY_DIRECTOR · EMD Serono Research & Development Institute, Inc.

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Arm 1, 2 and 3: Overall SurvivalTime from date of randomization to death, assessed approximately up to average of 19 months