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)

Recruitment Status
NOT YET RECRUITING
(See Contacts and Locations)Verified March 2026 by EMD Serono Research & Development Institute, Inc.
Sponsor
EMD Serono Research & Development Institute, Inc.
Information Provided by (Responsible Party)
EMD Serono Research & Development Institute, Inc.
Clinicaltrials.gov Identifier
NCT07549412
Other Study ID Numbers:
MS914001_0002
First Submitted
April 15, 2026
First Posted
April 23, 2026
Last Update Posted
April 23, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Metastatic Colorectal Cancer
Drug: Precemtabart tocentecanDrug: Precemtabart tocentecanDrug: Bevacizumab

Study Design

Study TypeInterventional
Actual Enrollment1020 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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)
Study Start DateMay 4, 2026
Actual Primary Completion Date2yrs 7mos from now
Actual Study Completion Date3yrs 5mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Arm 1: Precemtabart tocentecan (Precem-TcT) Monotherapy
Drug: Precemtabart tocentecan
Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.
Arm 2: Precem-TcT plus Bevacizumab
Drug: Precemtabart tocentecan
Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.
Arm 3: Trifluridine/Tipiracil (FTD-TPI) plus Bevacizumab
Drug: Bevacizumab
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.

Outcome Measures

Primary Outcome Measures
  1. Arm 1, 2 and 3: Overall Survival
Secondary Outcome Measures
  1. Arm 1 and Arm 2: Overall Survival
  2. Progression Free Survival (PFS)
  3. Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
  4. Duration of Response as Assessed by Investigator
  5. Number of Participants with Adverse Events (AEs) and Treatment Related Adverse Events
  6. Observed Concentration at End of Infusion (CEOI) Period
  7. Concentration Observed at the end of a Dosing Interval Immediately Before next Dosing (Ctrough)
  8. Number of Participants with Anti-Drug Antibody as measured by ADA assay
  9. Change from Baseline in Global Health Status, Physical, and Role Functioning Subscale Scores of European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
    EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsEMD Serono Research & Development Institute, Inc.
Locations
Please Contact U.S. Medical Information | Rockland Massachusetts, United States, 02370Please Contact the Communication Center | Darmstadt , Germany, 64293
Investigators
Study Director: Medical Responsible, EMD Serono Research & Development Institute, Inc.