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)

Official record

Identifier

NCT07549412

Recruiting locations

countries

United StatesArgentinaAustraliaAustriaBelgiumCanadaChinaFranceGermanyHong KongJapanPolandSouth KoreaSpainTaiwanUnited Kingdom

Interventions studied

Precemtabart tocentecanBevacizumabTrifluridine/Tipiracil (FTD-TPI)

Lead sponsor

EMD Serono Research & Development Institute, Inc.

Target enrolment

1020 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Recruiting

First posted

Apr 24, 2026

Last updated on the registry

Sep 9, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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

Indexed under

Colorectal Cancer