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
Recruiting now · Phase 1/Phase 2
Conditions studied: Non-Small Cell Lung Cancer, NSCLC, EGFR/HER2 Exon 20 Insertion Mutation
In brief
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.
Key facts
- Study ID
- NCT06043817
- Run by
- Pierre Fabre Medicament
- People needed
- 345
- Starts
- 2023-09-26
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope — Duarte, California, United States (enrolling)
- City of Hope — Huntington Beach, California, United States (enrolling)
- City of Hope — Irvine, California, United States (enrolling)
- Levine Cancer Institute - Charlotte — Charlotte, North Carolina, United States (enrolling)
- Thomas Jefferson University Research Facility — Philadelphia, Pennsylvania, United States (enrolling)
- SCRI Oncology Partners - PPDS — Nashville, Tennessee, United States (enrolling)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- University of Utah - Huntsman Cancer Institute - PPDS — Salt Lake City, Utah, United States (enrolling)
- NEXT Virginia — Fairfax, Virginia, United States (enrolling)
- EDOG Institut de Cancerologie de l'Ouest - PPDS — Saint-Herblain, Loire-Atlantique, France (enrolling)
- Institut Claudius Regaud - PPDS — Toulouse, France (enrolling)
- Gustave Roussy — Villejuif, France (enrolling)
- Charité - Universitätsmedizin Berlin (CBF) - Hindenburgdamm 30 — Berlin, Germany (enrolling)
- Universitätsklinikum Carl Gustav Carus an der TU Dresden — Dresden, Germany (enrolling)
- Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis — Amsterdam, Netherlands (enrolling)
- Chungbuk National University Hospital — Cheongju-si, South Korea (enrolling)
- CHA Bundang Medical Center, CHA University — Seongnam-si, South Korea (enrolling)
- Seoul National University Hospital — Seoul, South Korea (enrolling)
- Hospital Regional Universitario de Malaga - Hospital General — Málaga, Malaga, Spain (enrolling)
- Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON — Barcelona, Spain (enrolling)
- Hospital Universitario Ramon y Cajal — Madrid, Spain (enrolling)
- Hospital Universitario Virgen del Rocio — Seville, Spain (enrolling)
- National Taiwan University Hospital — Taipei, Taiwan (enrolling)
- Taipei Veterans General Hospital — Taipei, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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