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
Pierre Fabre Medicament
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. Has histologically- or cytologically confirmed diagnosis of NSCLC Stage IIIB/C or IV not eligible for curative intent surgery or chemoradiation 2. 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 mutations confirmed by qualified local laboratories 3. 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 more than 2, prior lines of approved treatment for advanced or metastatic N…
Interventions
- DrugSTX-721/PFL-721 (Escalated)
STX-721/PFL-721 dose will be escalated per cBLRM-design.
- DrugSTX-721/PFL-721 (3 dose levels)
Participants will receive STX-721/PFL-721 at one of three dose levels.
- DrugSTX-721/PFL-721 (RP2D)
Participants will receive the RP2D of STX-721/PFL-721.
Locations (24)
- City of HopeDuarte, California
- City of HopeHuntington Beach, California
- City of HopeIrvine, California
- Levine Cancer Institute - CharlotteCharlotte, North Carolina
- Thomas Jefferson University Research FacilityPhiladelphia, Pennsylvania
- SCRI Oncology Partners - PPDSNashville, Tennessee