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NCT06043817 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Non-Small Cell Lung Cancer and NSCLC, sponsored by Pierre Fabre Medicament.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 251
- Enrollment target
- 20
- Study locations
NCT06043817 is a Phase 1 study of Non-Small Cell Lung Cancer and NSCLC that is actively recruiting participants, run by Pierre Fabre Medicament. The registered enrollment target is 251 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT06043817, a Phase 1 study of Non-Small Cell Lung Cancer and NSCLC, is actively recruiting participants, sponsored by Pierre Fabre Medicament.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 251 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG STX-721/PFL-721 (Escalated)
- DRUG STX-721/PFL-721 (3 dose levels)
- DRUG STX-721/PFL-721 (RP2D)
Study Locations (20)
Other
- Institut Claudius Regaud - PPDS - Toulouse
- Gustave Roussy - Villejuif
- Charité - Universitätsmedizin Berlin (CBF) - Hindenburgdamm 30 - Berlin
- Universitätsklinikum Carl Gustav Carus an der TU Dresden - Dresden
- Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis - Amsterdam
- Chungbuk National University Hospital - Cheongju-si
- CHA Bundang Medical Center, CHA University - Seongnam-si
- Seoul National University Hospital - Seoul
- Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON - Barcelona
California
- City of Hope - Duarte
- City of Hope - Huntington Beach
- City of Hope - Irvine
North Carolina
- Levine Cancer Institute - Charlotte - Charlotte
Pennsylvania
- Thomas Jefferson University Research Facility - Philadelphia
Tennessee
- SCRI Oncology Partners - PPDS - Nashville
Texas
- University of Texas MD Anderson Cancer Center - Houston
Utah
- University of Utah - Huntsman Cancer Institute - PPDS - Salt Lake City
Virginia
- NEXT Virginia - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2023-09-26 |
| Est. Completion | 2029-12-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06043817
The ClinicalTrials.gov registry entry for NCT06043817 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 251 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (62% lower). The listed sponsor is Pierre Fabre Medicament, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which STX-721/PFL-721 (Escalated) is the first listed.
NCT06043817 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT06043817 about?
NCT06043817 is a clinical study titled "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) mutatio...
What is the current status of trial NCT06043817?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 251 participants. The study started on 2023-09-26. Estimated completion is 2029-12-01.
What conditions does trial NCT06043817 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, NSCLC, EGFR/HER2 Exon 20 Insertion Mutation.
What interventions are being tested in trial NCT06043817?
The interventions under investigation include: STX-721/PFL-721 (Escalated) (DRUG), STX-721/PFL-721 (3 dose levels) (DRUG), STX-721/PFL-721 (RP2D) (DRUG).
Who is sponsoring clinical trial NCT06043817?
This trial is sponsored by Pierre Fabre Medicament, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06043817 being conducted?
This trial has 20 study locations across California, North Carolina, Pennsylvania, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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