NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

Study acronym: FORTRESS
StatusActive, Not Recruiting
PhasePhase 1
SponsorAkamis Bio
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 1 entry Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 21 words
    • Site details revised at 7 of 7 sites
    • Publications: details revised at 1 of 1 entry
  2. Primary completion pushed from Nov 30, 2026 to Dec 30, 2026
    • Study completion pushed from Nov 30, 2028 to Dec 30, 2028
    • Study sites: 6 to 7
    v12
  3. Primary endpoint revisedv11
  4. Study sites: 5 to 6v10
  5. Primary completion date: May 31, 2026 to Nov 30, 2026
    • Study completion date: May 28, 2028 to Nov 30, 2028
    • Eligibility criteria expanded, about 2 words
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 4 to 5
    • Primary completion date: Feb 28, 2026 to May 31, 2026
    • Study completion date: Jan 30, 2029 to May 28, 2028
    v8
  2. Study sites: 3 to 4v7
  3. Study sites revised (3)v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 3
    • Start date changed from estimate of Mar 31, 2025 to Apr 7, 2025
    v5
  5. Site contacts updated at 1 of 2 sitesv4
  6. Start date: Feb 15, 2025 to Mar 31, 2025
    • Study sites: 0 to 2
    v3
  7. Start date: Nov 15, 2024 to Feb 15, 2025v2
  1. Study First Submitted
  • 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.
The FORTRESS trial (NG-350A-03) is an open-label, single-arm, and multicentre trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with locally advanced rectal cancer (LARC) and at least one risk factor for local or distant recurrence.
Trial Details
NCT Number NCT06459869
Lead Sponsor Akamis Bio
Conditions
(from sponsor)		 Locally Advanced Rectal Cancer (LARC)
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov