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 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: MS914001_00022025-524648-37-00
• Study Type: interventional
• Target: 1,020
• Locations: 2 countries
• Sites: 2

Brief 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 trifluoride/tipiracil (FTD-TPI) plus bevacizumab.

Conditions

Metastatic Colorectal Cancer

Keywords

CEACAM5; Antibody-drug conjugate; Exatecan; M9140; Precem-TcT

Outcome Measures

Primary Outcomes (1)

• Arm 1, 2 and 3: Overall Survival

  Time from date of randomization to death, assessed approximately up to average of 19 months

Secondary Outcomes (9)

• Arm 1 and Arm 2: Overall Survival

  Time from date of randomization to death, assessed approximately up to average of 19 months

• Progression Free Survival (PFS)

  Time from randomization to the first occurrence of disease progression or death, whichever occurs first (assessed up to average of 19 months)

• Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator

  Up to average of 19 months

• Duration of Response as Assessed by Investigator

  Time from first documentation of objective response to PD or death (assessed up to average of 19 months)

• Number of Participants with Adverse Events (AEs) and Treatment Related Adverse Events

  Up to average of 19 months

Study Arms (3)

Arm 1: Precemtabart tocentecan (Precem-TcT) Monotherapy

EXPERIMENTAL

Drug: Precemtabart tocentecan

Arm 2: Precem-TcT plus Bevacizumab

EXPERIMENTAL

Drug: Precemtabart tocentecan; Drug: Bevacizumab

Arm 3: Trifluridine/Tipiracil (FTD-TPI) plus Bevacizumab

ACTIVE COMPARATOR

Drug: Bevacizumab; Drug: Trifluridine/Tipiracil (FTD-TPI)

Interventions

Precemtabart tocentecan DRUG

Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.

Also known as: Precem-TcT

Arm 1: Precemtabart tocentecan (Precem-TcT) Monotherapy; Arm 2: Precem-TcT plus Bevacizumab

Bevacizumab DRUG

Bevacizumab, administered intravenously every 3 weeks on Day 1 of each 21-day cycle or every 2 weeks on Day 1 and Day 15 of each 28-day cycle.

Arm 2: Precem-TcT plus Bevacizumab; Arm 3: Trifluridine/Tipiracil (FTD-TPI) plus Bevacizumab

Trifluridine/Tipiracil (FTD-TPI) DRUG

FTD-TPI, tablet, administered orally twice daily, on Days 1 to 5 and Days 8 to 12 of each 28-day cycle.

Arm 3: Trifluridine/Tipiracil (FTD-TPI) plus Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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

Sponsors & Collaborators

• EMD Serono Research & Development Institute, Inc.: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (2)

Please Contact U.S. Medical Information

Rockland, Massachusetts, 02370, United States

Location

Please Contact the Communication Center

Darmstadt, 64293, Germany

Location

Related Links

• Trial Awareness and Transparency website
• US Medical Information website, Medical Resources

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Trifluridine; tipiracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Medical Responsible

  EMD Serono Research & Development Institute, Inc.

  STUDY DIRECTOR

Central Study Contacts

US Medical Information

CONTACT

888-275-7376; eMediUSA@emdserono.com

Communication Center

CONTACT

+49 6151 72 5200; service@emdgroup.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 24, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): December 25, 2028
• Study Completion (Estimated): October 31, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
• Access Criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

Locations

US (1); DE (1)