Clinical trial · Interventional
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 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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Precemtabart tocentecan | Drug | — | UNRESOLVED |
| Trifluridine/Tipiracil (FTD-TPI) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1: Precemtabart tocentecan (Precem-TcT) Monotherapy
- interventionNames
- Drug: Precemtabart tocentecan
- type
- EXPERIMENTAL
- label
- Arm 2: Precem-TcT plus Bevacizumab
- interventionNames
- Drug: Precemtabart tocentecan
- Drug: Bevacizumab
- type
- ACTIVE_COMPARATOR
- label
- Arm 3: Trifluridine/Tipiracil (FTD-TPI) plus Bevacizumab
- interventionNames
- Drug: Bevacizumab
- Drug: Trifluridine/Tipiracil (FTD-TPI)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Other protocol defined exclusion criteria may apply
References
Publications (0)
Data not yet available