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Feasibility and Safety of IMP321 (Eftilagimod Alpha) for Advanced Stage Solid Tumors

Study acronym: INSIGHT
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 19, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 110 to confirmed 83
    • Site details revised at 12 of 12 sites
    v22
  2. Primary and study completion dates: Sep 30, 2025 to Sep 30, 2026
    • Eligibility criteria shortened, about 38 words
    • Study description expanded, about 9 words
    v21
  3. Collaborators expanded, about 2 wordsv20
  4. Study sites: 8 to 12
    • Eligibility criteria expanded, about 1 word
    v19
  5. Study sites: 7 to 8v18
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 4 to 7v17
  2. Study sites: 3 to 4v16
  3. Study sites: 1 to 3v15
  4. Enrollment target: 45 to 110v14 Show 4 more changesShow less
    • Primary and study completion dates: Jun 30, 2024 to Sep 30, 2025
    • Eligibility criteria expanded, about 432 words
    • Site contact updated
    • Study arms: 4 to 5
  5. Site contact updated
    • Study title expanded, about 2 words
    v13
  6. Re-verified, no change to tracked fieldsv12
  7. Enrollment target: 26 to 45
    • Primary and study completion dates: Apr 14, 2021 to Jun 30, 2024
    • Trial status: Completed to Recruiting
    • Site details revised
    v11
  8. Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates changed from estimate of Apr 2021 to Apr 14, 2021
    v10
  9. Primary completion date: Nov 2019 to Apr 2021v9 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 50 to confirmed 26
    • Study completion date: Sep 2020 to Apr 2021
    • Site details revised
  10. Enrollment target: 38 to 50v8 Show 7 more changesShow less
    • Primary completion date: Aug 2019 to Nov 2019
    • Study completion date: Feb 2020 to Sep 2020
    • Interventions: IMP321 (Drug) to Avelumab (Drug), IMP321 (Drug)
    • Eligibility criteria expanded, about 371 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study arms: 3 to 4
    • Study description expanded, about 3 words
  11. Primary completion date: Feb 2019 to Aug 2019
    • Study completion date: Mar 2020 to Feb 2020
    v7
  12. Re-verified, no change to tracked fieldsv6
  13. Study completion date: Feb 2019 to Mar 2020
    • Eligibility criteria expanded, about 32 words
    • Site contact updated
    v5
  14. Lead sponsor: Krankenhaus Nordwest to Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwestv4
  15. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2017 to Aug 15, 2017
    • Site details revised
    v3
  16. Secondary endpoints revised (5)v2
  1. 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 phase I trial aims to investigate a potential enhancement of IMP321 immune-activating effects by new routes of administration: direct injection of IMP321 into the tumor tissue; intra-peritoneal therapy; combination of chemotherapy and/or immunotherapy/targeted therapy with active immunotherapy
Trial Details
NCT Number NCT03252938
Lead Sponsor Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborators: Immutep S.A.S.
Conditions
(from sponsor)		 Solid Tumors, Peritoneal Carcinomatosis, NSCLC Adenocarcinoma, Urothelial Carcinoma
Related terms Carcinoma, Transitional Cell, Peritoneal Neoplasms
Enrollment 83 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov