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RECRUITING
NCT07549412
PHASE3

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)

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

Summary

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1020

Start Date

2026-05-06

Completion Date

2029-10-16

Last Updated

2026-05-08

Healthy Volunteers

No

Interventions

DRUG

Precemtabart tocentecan

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

DRUG

Bevacizumab

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.

DRUG

Trifluridine/Tipiracil (FTD-TPI)

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

Locations (3)

Profound Research LLC at Cancer and Leukemia Center

Troy, Michigan, United States

GenesisCare North Shore (Oncology)

St Leonards, New South Wales, Australia

Icon Cancer Centre Chermside

Chermside, Queensland, Australia