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
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,020
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Lead sponsor
EMD Serono Research & Development Institute, Inc.
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Start date
2026-05-06
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Number of sites
34
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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.
clinicaltrials.gov
Short title
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)
clinicaltrials.gov
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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-10-16
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First posted
2026-04-24
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Registry last updated
2026-08-14
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Primary completion date
2029-10-16
clinicaltrials.gov
Start date
2026-05-06
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Participants
1,020
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Participant count basis
Estimated
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Planned participants
1,020
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Protocol amendments
1
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Number of sites
34
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
EMD Serono Research & Development Institute, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07549412
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07549412
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Arm 1, 2 and 3: Overall Survival

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

  1. Arm 1 and Arm 2: Overall Survival

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

  2. Progression Free Survival (PFS)

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

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

    Timeframe: Up to average of 19 months

  4. Duration of Response as Assessed by Investigator

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

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

    Timeframe: Up to average of 19 months

  6. Observed Concentration at End of Infusion (CEOI) Period

    Timeframe: At end of infusion on Cycle 1 Day 1 and Cycle 3 Day 1 (Arm 1 and Arm 2 only; each cycle is for 21 days)

  7. Concentration Observed at the end of a Dosing Interval Immediately Before next Dosing (Ctrough)

    Timeframe: At end of dosing interval on Cycle1Day1,Cycle2Day1,Cycle3Day1,Cycle4Day1, Cycle5Day1,Cycle6Day1,Cycle7Day1 until treatment discontinuation(assessed up to average of 19months (Arm 1 and Arm 2 only; each cycle is for 21 days)

  8. Number of Participants with Anti-Drug Antibody as measured by ADA assay

    Timeframe: Predose(-4to0 hours)on Cycle1Day1,Cycle2 Day1,Cycle 3Day1,Cycle4Day1, Cycle8Day1;thereafter every 4cycles until treatment discontinuation(assessed up to average of 19 months) (Arm 1 and Arm 2 only; each cycle is for 21 days)

  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)

    Timeframe: Baseline, Cycle 1 Day 1 and Day 1 of every new cycle until treatment discontinuation (assessed up to average of 19 months).

    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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Rocky Mountain Cancer Centers, LLP- AuroraLone Tree, United StatesRecruiting
  • Florida Cancer Specialists-BroadwayFort Myers, United StatesRecruiting
  • Florida Cancer Specialists - St. Petersburg BayfrontSt. Petersburg, United StatesRecruiting
  • Florida Cancer Specialists East - FCS EAST - West Palm BeachWest Palm Beach, United StatesRecruiting
  • Illinois Cancer SpecialistsArlington Heights, United StatesRecruiting
  • Illinois CancerCare PCPeoria, United StatesRecruiting
  • Springfield ClinicSpringfield, United StatesRecruiting
  • Profound Research LLC at Cancer and Leukemia CenterSterling Heights, United StatesRecruiting
  • Minnesota Oncology Hematology, P.A.Saint Louis Park, United StatesRecruiting
  • Missouri Cancer Associates - 150518964Columbia, United StatesRecruiting
  • SCRI Oncology PartnersNashville, United StatesRecruiting
  • Texas Oncology, P.A. - Abilene - 300210366Abilene, United StatesRecruiting
  • Texas Oncology-South AustinAustin, United StatesRecruiting
  • Texas Oncology DFWBedford, United StatesRecruiting
  • Texas Oncology- San AntonioSan Antonio, United StatesRecruiting
  • Texas Oncology, P.A. - TylerTyler, United StatesRecruiting
  • Virginia Oncology AssociatesNewport News, United StatesRecruiting
  • Blue Ridge Cancer Care - 300202915Roanoke, United StatesRecruiting
  • GenesisCare North Shore (Oncology)St Leonards, AustraliaRecruiting
  • Icon Cancer Centre ChermsideChermside, AustraliaRecruiting
  • Mater Misericordiae Ltd - PARENTSouth Brisbane, AustraliaRecruiting
  • Flinders Medical CentreBedford Park, AustraliaRecruiting
  • University Health Network - Princess Margaret Cancer CentreToronto, CanadaRecruiting
  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaRecruiting
  • Sichuan Cancer HospitalChengdu, ChinaRecruiting

And 9 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-524648-37-00
  • jRCT2031260267
  • CTR20262356
Sources for references
clinicaltrials.gov

Related records

Drugs (4)

Collaborators (1)

Lead sponsors (1)

Conditions (2)

Targets (2)