Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later across 2 updates May 30, 2026 → Aug 30, 2027
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Record History

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  1. Primary completion pushed from Aug 30, 2026 to Aug 30, 2027 Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Study completion pushed from Oct 30, 2026 to Dec 30, 2027
    • Study sites: 2 to 3
    • Eligibility criteria expanded, about 23 words
  2. Primary completion pushed from May 30, 2026 to Aug 30, 2026v9
  3. Eligibility criteria expanded, about 321 words
    • Study description expanded, about 2 words
    v8
  4. Re-verified, no change to tracked fieldsv7
  5. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Apr 30, 2025 to May 30, 2026
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Apr 30, 2024 to May 15, 2024
    v5
  2. Primary completion date: Oct 30, 2024 to Apr 30, 2025
    • Start date: Oct 30, 2023 to Apr 30, 2024
    • Study completion date: Oct 30, 2025 to Oct 30, 2026
    v4
  3. Lead sponsor: Steba Biotech S.A. to Impact Biotech Ltd
    • Collaborators shortened, about 3 words
    v3
  4. Re-verified, no change to tracked fieldsv2
  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.
This is a prospective, multicenter, non-randomized, open label light dose escalation phase I trial to evaluate the safety and preliminary efficacy of Padeliporfin vascular targeted photodynamic therapy (VTP) applied via endovascular fiber placement within a dilatation catheter, through the target artery(superior mesenteric artery (SMA), celiac artery (CA) or common hepatic artery (CHA)). The investigators will evaluate safety and preliminary efficacy of Padeliporfin VTP administered endovascularly using light dose escalation.
Trial Details
NCT Number NCT05919238
Lead Sponsor Impact Biotech Ltd
Conditions
(from sponsor)		 Locally Advanced Unresectable Pancreatic Adenocarcinoma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov