Precemtabart Tocentecan Phase 3 Colorectal Cancer Study
Summary
NIH registered a Phase 3 clinical trial (NCT07549412, PROCEADE-CRC-03) on April 24, 2026, evaluating precemtabart tocentecan (Precem-TcT) with or without bevacizumab against trifluridine/tipiracil plus bevacizumab in participants with previously treated metastatic colorectal cancer (mCRC). The study enrolls patients who have already received prior treatment with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, and aims to demonstrate overall survival prolongation as the primary endpoint. Results of this Phase 3 trial could influence competitive dynamics in the second-line mCRC treatment landscape.
“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.”
About this source
ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.
What changed
NIH registered a new Phase 3 clinical trial on ClinicalTrials.gov on April 24, 2026. The study (NCT07549412, PROCEADE-CRC-03) will evaluate precemtabart tocentecan as a single agent or in combination with bevacizumab against the standard trifluridine/tipiracil plus bevacizumab regimen in patients with metastatic colorectal cancer who have progressed after prior irinotecan, oxaliplatin, fluoropyrimidine, and bevacizumab treatment.
For sponsors developing oncology therapies, this trial registration signals competitive activity in the heavily treated mCRC space and may inform development strategy and competitive positioning. The overall survival endpoint underscores the high unmet need in this patient population. Clinical operations teams should monitor enrollment criteria alignment with their own development programs.
Archived snapshot
Apr 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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)
Phase 3 NCT07549412 Kind: PHASE3 Apr 24, 2026
Abstract
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.
Conditions: Metastatic Colorectal Cancer
Interventions: Precemtabart tocentecan, Bevacizumab, Trifluridine/Tipiracil (FTD-TPI)
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.