Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

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 trifluridine/tipiracil (FTD-TPI) plus bevacizumab.

Official Title

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)

Keywords

Metastatic Colorectal Cancer, CEACAM5, Antibody-drug conjugate, Exatecan, M9140, Precem-TcT, Colorectal Neoplasms, Bevacizumab, Trifluridine, tipiracil, Precemtabart tocentecan, Trifluridine/Tipiracil (FTD-TPI), Precemtabart tocentecan (Precem-TcT) Monotherapy, Precem-TcT plus Bevacizumab, Trifluridine/Tipiracil (FTD-TPI) plus Bevacizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

  • UCSF Mount Zion Medical Ctr accepting new patients
    San Francisco California 94158 United States
  • BC Cancer - Vancouver - BC Cancer Agency accepting new patients
    Vancouver British Columbia V5Z 4E6 Canada

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
EMD Serono Research & Development Institute, Inc.
Links
Trial Awareness and Transparency website US Medical Information website, Medical Resources
ID
NCT07549412
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1020 study participants
Last Updated