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

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 ID
NCT06043817
Phase
PHASE1 / PHASE2
Sponsor
Pierre Fabre Medicament
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • STX-721/PFL-721 (Escalated)
  • STX-721/PFL-721 (3 dose levels)
  • STX-721/PFL-721 (RP2D)
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Huntington Beach, California, United States|33.6603,-117.99923
  • Irvine, California, United States|33.66946,-117.82311
  • Charlotte, North Carolina, United States|35.22709,-80.84313
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362

Key Eligibility Criteria

  • Has histologically- or cytologically confirmed diagnosis of NSCLC Stage IIIB/C or IV not eligible for curative intent surgery or chemoradiation
  • Part 1: Tumor tissue EGFR or HER2 exon 20 insertion mutations confirmed by qualified local laboratories. Parts 2 and 3: EGFR/HER2 exon 20 insertion…
  • Part 1: Has received all approved therapies for advanced or metastatic NSCLC or is ineligible. Part 2 and Part 3: Has received at least 1, but not …
  • Has documented tumor progression (based on radiological imaging)

For full eligibility, visit ClinicalTrials.gov.

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