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NCT06567015 · ClinicalTrials.gov registry record · Phase 1
Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs
A Phase 1 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Pierre Fabre Medicament.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 171
- Enrollment target
- 16
- Study locations
NCT06567015: Recruiting Phase 1 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Pierre Fabre Medicament.
NCT06567015 is a Phase 1 study of Non-small Cell Lung Cancer (NSCLC) that is actively recruiting participants, run by Pierre Fabre Medicament. The registered enrollment target is 171 participants, below the 282-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (39% lower). The trial reports 16 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06567015, a Phase 1 study of Non-small Cell Lung Cancer (NSCLC), is actively recruiting participants, sponsored by Pierre Fabre Medicament.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 171 participants
- Enrollment target
- 16
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG STX-241
Study Locations (16)
Other
- Shanghai East Hospital, Tongji University - Shanghai
- Tianjin Medical University Cancer Institute and Hospital - Tianjin
- Centre Léon Bérard - Lyon
- CHU Hôpital de la Timone - Marseille
- Institut de Cancérologie de l'Ouest (ICO) - René Gauducheau - Saint-Herblain
- Institut Universitaire du Cancer de Toulouse - Oncopole - Toulouse
- Gustave Roussy - Villejuif
- Universitätsklinikum Carl Gustav Carus Dresden - Dresden
- Netherlands Cancer Institute - Amsterdam
- Vall d'Hebron Institut d'Oncologia - Barcelona
- Hospital Universitario La Paz - Madrid
- Centro Integral Oncológico Clara Campal (CIOCC) - Madrid
- National Taiwan University Hospital - Taipei
- Taipei Veterans General Hospital - Taipei
Tennessee
- Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium) - Nashville
Texas
- Oncology Consultants (OC) - Texas Medical Center - Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2024-09-17 |
| Est. Completion | 2030-07 |
| Phase | Phase 1 |
What NCT06567015 shows while recruiting
NCT06567015 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, below the 282-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 1 intervention - of which STX-241 is the first listed.
NCT06567015 lists 16 locations in 3 states (Other, Tennessee, Texas).
Frequently Asked Questions
What is clinical trial NCT06567015 about?
NCT06567015 is a clinical study titled "Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs". 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 Nervo...
What is the current status of trial NCT06567015?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 171 participants. The study started on 2024-09-17. Estimated completion is 2030-07.
What conditions does trial NCT06567015 study?
This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC).
What interventions are being tested in trial NCT06567015?
The interventions under investigation include: STX-241 (DRUG).
Who is sponsoring clinical trial NCT06567015?
This trial is sponsored by Pierre Fabre Medicament, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06567015 being conducted?
This trial has 16 study locations across Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-small Cell Lung Cancer (NSCLC)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06567015's enrollment target sits among peer trials
171 33rd of 59 higher than 27 of 59 other Non-small Cell Lung Cancer (NSCLC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-small Cell Lung Cancer (NSCLC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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