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Trial of ProAgio in Advanced/Metastatic Colorectal Cancer

StatusSuspended
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment suspended Sponsor's reason: temporary suspended Eligibility criteria expanded, about 34 words · Secondary endpoints: details revised at 2 of 4 entries · Site details revised Show 3 more changesShow less
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jun 2025 to Jul 17, 2025v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2025 to Jul 17, 2025
  3. Phase: Phase 1/2 to Phase 1v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with 5-fluorouracil, irinotecan (FOLFIRI) and bevacizumab for untreated advanced/metastatic CRC. The study will use an Accelerated titration BOIN design in Phase I to determine the recommended RP2D of ProAgio with FOLFIRI + bevacizumab. The trial will estimate the RP2D of ProAgio when combined with FOLFIRI + bevacizumab, starting from 2 dose levels lower than the estimated RP2D of ProAgio alone. Accelerated titration BOIN design will enroll patients with the 4 combination dose levels. Subjects will be selected based on following criteria: previously untreated advanced/metastatic CRC, ECOG performance status (0-1), and adequate organ functions. Subjects with recent surgeries, history of recent thromboembolic events or significant cardiovascular disease will be excluded. Once the MTD and RP2D of ProAgio with FOLFIRI have been identified, an expansion cohort of 12 subjects with advanced/metastatic CRC will begin. The purpose of the expansion cohort is to confirm the safety of the regimen and provide preliminary data on the activity of ProAgio + FOLFIRI + bevacizumab.
Trial Details
NCT Number NCT06867822
Lead Sponsor University of Alabama at Birmingham
Collaborators: The V Foundation
Conditions Advanced Colorectal Cancer, Metastatic Colorectal Cancer
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov