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)

Part of paid clinical trials in Troy, Michigan.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT07549412
Phase
PHASE3
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Precemtabart tocentecan — DRUG
    Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
May 6, 2026
Status verified
May 2026
Primary completion
Oct 16, 2029
Completion
Oct 16, 2029

Study Design

Enrollment
1,020 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Precemtabart tocentecan (Precem-TcT) Monotherapy
  • Experimental: Arm 2: Precem-TcT plus Bevacizumab
  • Active Comparator: Arm 3: Trifluridine/Tipiracil (FTD-TPI) plus Bevacizumab

Primary Outcome Measure

Arm 1, 2 and 3: Overall Survival [ Time Frame: Time from date of randomization to death, assessed approximately up to average of 19 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Profound Research LLC at Cancer and Leukemia CenterTroyMichigan48098-

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By research site
Profound Research LLC at Cancer and Leukemia Center· Troy, MI

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