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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)

RecruitingPhase 3

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)

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: EMD Serono Research & Development Institute, Inc. · Participants: 1,020 · Started: May 6, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07549412

Locations in the U.S.

ColoradoRocky Mountain Cancer Centers, LLP- Aurora, Lone Tree
FloridaFlorida Cancer Specialists-Broadway, Fort Myers
Florida Cancer Specialists - St. Petersburg Bayfront, St. Petersburg
Florida Cancer Specialists East - FCS EAST - West Palm Beach, West Palm Beach
IllinoisIllinois Cancer Specialists, Arlington Heights
Illinois CancerCare PC, Peoria
Springfield Clinic, Springfield
MichiganProfound Research LLC at Cancer and Leukemia Center, Sterling Heights
MinnesotaMinnesota Oncology Hematology, P.A., Saint Louis Park
MissouriMissouri Cancer Associates - 150518964, Columbia
New YorkWhite Plains Hospital Medical and Wellness PRIME, White Plains
TennesseeSCRI Oncology Partners, Nashville
TexasTexas Oncology, P.A. - Abilene - 300210366, Abilene
Texas Oncology-South Austin, Austin
Texas Oncology DFW, Bedford
Texas Oncology- San Antonio, San Antonio
Texas Oncology, P.A. - Tyler, Tyler
VirginiaVirginia Oncology Associates, Newport News
Blue Ridge Cancer Care - 300202915, Roanoke

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.