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Metastatic Colorectal CancerCancerDrugPhase 3

What this study is

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 trifluridine/tipiracil (FTD-TPI) plus bevacizumab.

What's being tested

  • Precemtabart tocentecan

    Intervention · DRUG

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

  • Bevacizumab

    Intervention · DRUG

    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)

    Intervention · DRUG

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

Study details

Official title
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)
Sponsor
EMD Serono Research & Development Institute, Inc.
Conditions
Metastatic Colorectal Cancer
Enrolling
1,020 people
Starts
2026-05-06
Est. completion
2029-10-16
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗