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A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours

StatusRecruiting
PhasePhase 1/2
SponsorIpsen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 31 words Site details revised at 3 of 12 sites Show 1 more changeShow less
    • Site details revised at 3 of 12 sites
  2. Site details revised at 1 of 12 sitesv11
  3. Re-verified, no change to tracked fieldsv10
  4. Site details revised at 1 of 12 sitesv9
  5. Site details revised at 3 of 12 sitesv8
Show 6 earlier versionsHide 6 earlier versions
  1. Site details revised at 3 of 12 sitesv7
  2. Re-verified, no change to tracked fieldsv6
  3. Enrollment target: 102 to 114v5
  4. Start date: Nov 5, 2025 to Dec 5, 2025 Study sites: 1 to 12v4 Show 1 more changeShow less
    • Study sites: 1 to 12
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Oct 30, 2025 to Nov 5, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 30, 2025 to Nov 5, 2025
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Ipsen
46 trials monitored
See 4 trials at risk
This study aims to find the right dosage and evaluate the safety and effectiveness of the drug IPN60300 in adults with advanced solid tumours, which are cancers that have spread to other parts of the body from their original location. All participants will receive the drug by injection. Study Phases: * Phase Ia: Participants with certain types of tumours will be treated in cohorts of increasingly higher doses of the drug to determine the safe and effective dose range (a high and a low dose). * Phase Ib: Participants with a specific tumour type will receive one of the two doses identified in phase Ia. The dose level will be assigned randomly (by chance). Study Periods: Screening: Up to 28 days before first IPN60300 injection to determine eligibility. Treatment: Starts with the first dose of IPN60300 and continues until it needs to be stopped due to harmful effects, the disease getting worse, or if the participant decides to stop taking part in the study, the investigator's decision to stop treatment, death or the study is terminated early by the sponsor. Participants will undergo blood tests, urine collections, physical examinations, and clinical evaluations.
Trial Details
NCT Number NCT07213817
Lead Sponsor Ipsen
Conditions Locally Advanced Solid Tumor, Metastatic Solid Tumor
Enrollment 114 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov