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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)

NCT07549412

RecruitingPhase 3

Sponsor: EMD Serono Research & Development Institute, Inc.

Conditions: Metastatic Colorectal Cancer

Interventions: Precemtabart tocentecan, Bevacizumab, Trifluridine/Tipiracil (FTD-TPI)

Countries: United States, Australia, Canada, Japan, South Korea, Taiwan

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (21)

Lone Tree, Colorado, United States
Arlington Heights, Illinois, United States
Peoria, Illinois, United States
Springfield, Illinois, United States
Sterling Heights, Michigan, United States
Saint Louis Park, Minnesota, United States
Columbia, Missouri, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Austin, Texas, United States
Bedford, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Newport News, Virginia, United States
Roanoke, Virginia, United States
St Leonards, New South Wales, Australia
Chermside, Queensland, Australia
Toronto, Ontario, Canada
Chūōku, Tokyo-To, Japan
Seoul, South Korea
Taichung, Taiwan