Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06567015 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs

Study acronym: STX-241 FIH
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 16 to 18 Eligibility criteria expanded, about 5 wordsv14 Show 1 more changeShow less
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria expanded, about 126 words Study sites revised (16)v13 Show 1 more changeShow less
    • Study sites revised (16)

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 2 of 16 sitesv12
  4. Site details revised at 1 of 16 sitesv11
  5. Site details revised at 16 of 16 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Eligibility criteria revised Site details revised at 3 of 16 sitesv9 Show 1 more changeShow less
    • Site details revised at 3 of 16 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria expanded, about 134 wordsv8 See this version in full on ClinicalTrials.gov ↗
  3. Primary endpoints: 7 to 6 Eligibility criteria shortened, about 13 words · Secondary endpoints: 24 to 18 · Site details revised at 2 of 16 sitesv7 Show 3 more changesShow less
    • Eligibility criteria shortened, about 13 words
    • Secondary endpoints: 24 to 18
    • Site details revised at 2 of 16 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 14 to 16v6
  5. Re-verified, no change to tracked fieldsv5
  6. Site details revised at 4 of 14 sitesv4
  7. Trial status: Not Yet Recruiting to Recruiting Study sites: 13 to 14 · Start date changed from estimate of Oct 5, 2024 to Sep 17, 2024v3 Show 2 more changesShow less
    • Study sites: 13 to 14
    • Start date changed from estimate of Oct 5, 2024 to Sep 17, 2024
  8. Start date: Sep 5, 2024 to Oct 5, 2024 Site contacts updated at 13 of 13 sitesv2 Show 1 more changeShow less
    • Site contacts updated at 13 of 13 sites
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this First-In-Human (FIH) Phase I/II trial is to establish the safety profile, determine the Recommended Phase II Dose (RP2D), explore the pharmacokinetic (PK) exposure and pharmacodynamic (PD) properties as well as assess the efficacy of STX-241/PFL-241, a mutant selective Central Nervous System (CNS)-penetrant fourth generation EGFR TKI, in participants with locally advanced or metastatic NSCLC that progressed during or following third generation EGFR TKI such as osimertinib due to C797X double acquired (secondary) mutations.
Trial Details
NCT Number NCT06567015
Lead Sponsor Pierre Fabre Medicament
Conditions Non-small Cell Lung Cancer (NSCLC)
Enrollment 171 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov