Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07662031
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Tovecimig — BIOLOGICAL
    Tovecimig is provided in 10 mg/kg dose intravenously over the course of 60 minutes on Day 1 and Day 15 of a 28-day cycle.
  • Irinotecan — DRUG
    Standard of care irinotecan will be given at a dose of 180 mg/m\^2 intravenously on Day 1 and Day 15 of each 28-day cycle as part of the FOLFIRI treatment regimen.
  • Leucovorin — DRUG
    Standard of care leucovorin will be given at a dose of 400 mg/m\^2 intravenously on Day 1 and Day 15 of each 28-day cycle as part of the FOLFIRI treatment regimen.
  • 5-Fluorouracil (5-FU) — DRUG
    Standard of care 5-FU will be given at a dose of 2400 mg/m\^2 in continuous infusion over 46 hours on Days 1-2 and Days 15-16 of each 28-day cycle as part of the FOLFIRI treatment regimen.

Study Details

This is an open-label Phase 2 study to evaluate the safety and efficacy of Tovecimig combined with FOLFIRI in patients who have received one prior line of therapy for advanced or metastatic colorectal cancer (CRC).

Key Dates

Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2032

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tovecimig and Irinotecan + Leucovorin + 5-Fluorouracil (FOLFIRI regimen)
    Treatment will be administered in 28-day cycles. On Day 1 and 15 of each cycle, patients will receive Tovecimig followed by the FOLFIRI regimen.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Start of treatment to completion of treatment (estimated time up to 12 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Olivia Aranha, MD, PhD
[email protected]
557-747-2105
Olivia Aranha, MD, PhD (PRINCIPAL_INVESTIGATOR)
Erika Belmont, MD (SUB_INVESTIGATOR)
Roheena Z Panni, MD, MPHS (SUB_INVESTIGATOR)
Valerie Prashad, PharmD (SUB_INVESTIGATOR)
Esther Lu, PhD (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Washington University School of Medicine· St Louis, MO

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