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 · NCT06043817 · Interventional (participants receive a specific treatment) · Lead sponsor: Pierre Fabre Medicament
View the official record on ClinicalTrials.gov →Interventions studied
STX-721/PFL-721 (3 dose levels)STX-721/PFL-721 (Escalated)STX-721/PFL-721 (RP2D)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Has histologically- or cytologically confirmed diagnosis of NSCLC Stage IIIB/C or IV not eligible for curative intent surgery or chemoradiation
- 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
- 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 NSCLC, 1 of which must be platinum-based chemotherapy unless contraindicated
- Has documented tumor progression (based on radiological imaging)
- Has new or recent tumor biopsy (collected at screening, if feasible) or archival tumor specimen collected in the past 10 years available for genomic profiling
- Has at least one measurable tumor lesion per RECIST v1.1
- Is ≥18 years of age at the time of signing the ICF
- Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Key
Exclusion criteria
- Has a tumor that is known to harbor EGFR ex20ins p.H773\_V774insH variant, or any EGFR kinase domain activating mutation concurrent with either a T790M and/or C797S resistance mutations
- Has history (within ≤2 years before screening) of solid tumor or hematological malignancy that is histologically distinct from NSCLC
- Has symptomatic brain or spinal metastases
- Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE Grade ≤1, except for alopecia and peripheral neuropathy
- Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., could compromise the participant's well-being) or would prevent, limit, or confound the protocol-specified assessments
Where it is running
25 locations listed across 7 US states.
- City of Hope - Duarte, California, United States
- City of Hope - Huntington Beach, California, United States
- City of Hope - Irvine, California, United States
- Levine Cancer Institute - Charlotte - Charlotte, North Carolina, United States
- Thomas Jefferson University Research Facility - Philadelphia, Pennsylvania, United States
- SCRI Oncology Partners - PPDS - Nashville, Tennessee, United States
- University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- University of Utah - Huntsman Cancer Institute - PPDS - Salt Lake City, Utah, United States
- NEXT Virginia - Fairfax, Virginia, United States
- Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis - Amsterdam, Netherlands
- Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON - Barcelona, Spain
- Charité - Universitätsmedizin Berlin (CBF) - Hindenburgdamm 30 - Berlin, Germany
- Chungbuk National University Hospital - Cheongju-si, South Korea
- Universitätsklinikum Carl Gustav Carus an der TU Dresden - Dresden, Germany
- Hospital Universitario Ramon y Cajal - Madrid, Spain
- CHA Bundang Medical Center, CHA University - Seongnam-si, South Korea
- Seoul National University Hospital - Seoul, South Korea
- Hospital Universitario Virgen del Rocio - Seville, Spain
- National Taiwan University Hospital - Taipei, Taiwan
- Taipei Veterans General Hospital - Taipei, Taiwan
- Institut Claudius Regaud - PPDS - Toulouse, France
- Gustave Roussy - Villejuif, France
- START - Rioja Hospital Universitario San Pedro - Logroño, La Rioja, Spain
- EDOG Institut de Cancerologie de l'Ouest - PPDS - Saint-Herblain, Loire-Atlantique, France
- Hospital Regional Universitario de Malaga - Hospital General - Málaga, Malaga, Spain