Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Pierre Fabre Medicament
Study ID
NCT06567015
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • STX-241 — DRUG
    Film-coated tablet Route of administration: Oral

Study Details

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.

Key Dates

Start date
Sep 17, 2024
Status verified
Apr 2026
Primary completion
Nov 20, 2027
Completion
Jul 31, 2030

Study Design

Enrollment
171 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: STX-241/PFL-241
    Part 1: Dose Escalation and Backfilling components (Phase Ia) Participants will receive oral (PO) STX-241/PFL-241 twice daily (BID) at fixed doses: 10 mg, 20 mg, 40 mg, 80 mg, 120 mg, 180 mg on a continuous dosing schedule Part 2: Dose Range Optimization (Phase Ib). Participants will receive oral (PO) STX-241/PFL-241 twice daily (BID) at fixed doses selected from Part 1 within the OBD-MTD range for Part 2 on a continuous dosing schedule.

Primary Outcome Measure

Safety: Part 1 and Part 2: Safety: Incidence and severity of treatment emergent adverse events (TEAEs)/serious adverse events (SAEs), according to NCI-CTCAE v5.0 criteria. [ Time Frame: Screening to Safety Follow-up (30 days post last dose) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)NashvilleTennessee37203
Melissa Johnson, Dr. (PRINCIPAL_INVESTIGATOR)
Oncology Consultants (OC) - Texas Medical Center - Cancer CenterHoustonTexas77030
Julio Peguero, Dr (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By research site
Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)· Nashville, TNOncology Consultants (OC) - Texas Medical Center - Cancer Center· Houston, TX

Related Studies