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First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations

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

Record History

  1. Study sites: 24 to 25v16
  2. Enrollment increased: 251 → 345 participantsv15
  3. Eligibility criteria expanded, about 1 wordv14 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 23 to 24v13
  5. Lead sponsor: Antares Therapeutics, Inc to Pierre Fabre Medicament Primary completion date: Jun 1, 2027 to Dec 1, 2029 · Primary endpoints revised (8) · Enrollment target: 185 to 251 · 5 morev12 Show 8 more changesShow less
    • Primary completion date: Jun 1, 2027 to Dec 1, 2029
    • Primary endpoints revised (8)
    • Enrollment target: 185 to 251
    • Study sites: 21 to 23
    • Completion date: Jun 1, 2028 to Dec 1, 2029
    • Interventions: STX-721 (3 dose levels) (Drug), STX-721 (Escalated) (Drug), STX-721 (RP2D) (Drug) to STX-721/PFL-721 (3 dose levels) (Drug), STX-721/PFL-721 (Escalated) (Drug), STX-721/PFL-721 (RP2D) (Drug)
    • Eligibility criteria revised
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 20 to 21v11
  2. Lead sponsor: Eli Lilly and Company to Antares Therapeutics, Inc Enrollment target: 120 to 185 · Interventions: STX-721 (2 doses) (Drug), STX-721 (Escalated) (Drug), STX-721 (RP2D) (Drug) to STX-721 (3 dose levels) (Drug), STX-721 (Escalated) (Drug), STX-721 (RP2D) (Drug)v10 Show 2 more changesShow less
    • Enrollment target: 120 to 185
    • Interventions: STX-721 (2 doses) (Drug), STX-721 (Escalated) (Drug), STX-721 (RP2D) (Drug) to STX-721 (3 dose levels) (Drug), STX-721 (Escalated) (Drug), STX-721 (RP2D) (Drug)
  3. Study sites: 18 to 20v9
  4. Study sites: 15 to 18v8
  5. Primary endpoints: 12 to 8 Eligibility criteria expanded, about 91 wordsv7 Show 1 more changeShow less
    • Eligibility criteria expanded, about 91 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 5 to 15v6
  7. Study sites: 4 to 5v5
  8. Site details revised at 3 of 4 sitesv4
  9. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jul 17, 2026 to Jun 1, 2027 · Study sites: 1 to 4 · Completion date: May 1, 2028 to Jun 1, 2028 · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Jul 17, 2026 to Jun 1, 2027
    • Study sites: 1 to 4
    • Completion date: May 1, 2028 to Jun 1, 2028
    • Start date changed from estimate of Sep 25, 2023 to Sep 26, 2023
  10. Interventions: STX-721 (Drug), STX-721 (Drug), STX-721 (Drug) to STX-721 (2 doses) (Drug), STX-721 (Escalated) (Drug), STX-721 (RP2D) (Drug)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.
Study STX-721-101/PFL-721CI101 is an open label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721/PFL-721 in participants with non-small cell lung cancer (NSCLC) carrying EGFR or HER2 exon 20 insertion (ex20ins) mutations.
Trial Details
NCT Number NCT06043817
Lead Sponsor Pierre Fabre Medicament
Conditions Non-Small Cell Lung Cancer, NSCLC, EGFR/HER2 Exon 20 Insertion Mutation
Enrollment 345 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov