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
RECRUITING
(See Contacts and Locations)Verified July 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
August 13, 2026
Last Verified
July 2026

ClinicalTrials.gov processed this data on August 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 5, 2026
Actual Primary Completion Date3yrs 1mo from now
Actual Study Completion Date3yrs 1mo 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
Rocky Mountain Cancer Centers, LLP- Aurora | Lone Tree Colorado, United States, 80124Florida Cancer Specialists-Broadway | Fort Myers Florida, United States, 33901Florida Cancer Specialists - St. Petersburg Bayfront | St. Petersburg Florida, United States, 33701-4553Florida Cancer Specialists East - FCS EAST - West Palm Beach | West Palm Beach Florida, United States, 33401Illinois Cancer Specialists | Arlington Heights Illinois, United States, 60005Illinois CancerCare PC | Peoria Illinois, United States, 61615-7822Springfield Clinic | Springfield Illinois, United States, 62702Profound Research LLC at Cancer and Leukemia Center | Sterling Heights Michigan, United States, 48098Minnesota Oncology Hematology, P.A. | Saint Louis Park Minnesota, United States, 55416Missouri Cancer Associates - 150518964 | Columbia Missouri, United States, 65201SCRI Oncology Partners | Nashville Tennessee, United States, 37203Texas Oncology, P.A. - Abilene - 300210366 | Abilene Texas, United States, 79606Texas Oncology-South Austin | Austin Texas, United States, 78745Texas Oncology DFW | Bedford Texas, United States, 75246Texas Oncology- San Antonio | San Antonio Texas, United States, 78240Texas Oncology, P.A. - Tyler | Tyler Texas, United States, 75702Virginia Oncology Associates | Newport News Virginia, United States, 23606Blue Ridge Cancer Care - 300202915 | Roanoke Virginia, United States, 24014-2419GenesisCare North Shore (Oncology) | St Leonards New South Wales, Australia, 2065Icon Cancer Centre Chermside | Chermside Queensland, Australia, 4032Mater Misericordiae Ltd - PARENT | South Brisbane Queensland, Australia, 4101Flinders Medical Centre | Bedford Park South Australia, Australia, 5042University Health Network - Princess Margaret Cancer Centre | Toronto Ontario, Canada, M5G 2M9Sun Yat-sen University Cancer Center | Guangzhou Guangdong, China, 510060Sichuan Cancer Hospital | Chengdu Sichuan, China, 610041Kanagawa Cancer Center - Dept of Gastroenterology | Yokohama Kanagawa, Japan, 241-8515Kindai University Hospital | Sakai-shi Osaka, Japan, 590-0197National Cancer Center Hospital | Chūōku Tokyo-To, Japan, 104-0045Cancer Institute Hospital of JFCR | Kōtoku Tokyo-To, Japan, 135-8550Kyungpook National University Chilgok Hospital | Daegu Gyeongsangnam-do, South Korea, 700-721Severance Hospital, Yonsei University Health System - Division of Infectious Diseases | Seoul , South Korea, 03722Samsung Medical Center | Seoul , South Korea, 06351The Catholic University of Korea, Seoul St. Maryâ | Seoul , South Korea, 06591China Medical University Hospital | Taichung , Taiwan, 40447
Investigators
Study Director: Medical Responsible, EMD Serono Research & Development Institute, Inc.