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Clinical Trial ● Currently Recruiting Phase III 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)

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 • Phase III…

📅 09 Sep 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase III
NCT ID
NCT07549412
Sponsor
EMD Serono Research & Development Institute, Inc.
Start
2026-05-06
ClinicaliQ Trial Snapshot
  • 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 • Phase III • Oncology • NCT07549412.
  • What is being tested: Precemtabart tocentecan (Precem-TcT), administered with or without bevacizumab, is being compared against the standard treatment of trifluridine/tipiracil plus bevacizumab in heavily pre-treated metastatic colorectal cancer, with overall survival as the primary endpoint.
  • Patient eligibility overview: The trial targets patients with metastatic colorectal cancer who have exhausted standard first and second-line chemotherapy regimens (irinotecan, oxaliplatin, fluoropyrimidine, and bevacizumab), representing a treatment-refractory population with limited options.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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.

Eligibility Snapshot
  • : * 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

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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