RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Pierre Fabre Medicament • ClinicalTrials.gov ID: NCT06043817

Registry updated: 2026-09-02

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Description

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.

Interventions

STX-721/PFL-721 (Escalated) (Drug)
STX-721/PFL-721 dose will be escalated per cBLRM-design.
STX-721/PFL-721 (3 dose levels) (Drug)
Participants will receive STX-721/PFL-721 at one of three dose levels.
STX-721/PFL-721 (RP2D) (Drug)
Participants will receive the RP2D of STX-721/PFL-721.

Eligibility criteria

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 NSCLC, 1 of which must be platinum-based chemotherapy unless contraindicated 4. Has documented tumor progression (based on radiological imaging) 5. 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 6. Has at least one measurable tumor lesion per RECIST v1.1 7. Is ≥18 years of age at the time of signing the ICF 8. Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Key Exclusion Criteria: 1. 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 2. Has history (within ≤2 years before screening) of solid tumor or hematological malignancy that is histologically distinct from NSCLC 3. Has symptomatic brain or spinal metastases 4. Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE Grade ≤1, except for alopecia and peripheral neuropathy 5. 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

Conditions

Non-Small Cell Lung Cancer NSCLC EGFR/HER2 Exon 20 Insertion Mutation

Locations

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
EDOG Institut de Cancerologie de l'Ouest - PPDS — Saint-Herblain, Loire-Atlantique, France
Institut Claudius Regaud - PPDS — Toulouse, France
Gustave Roussy — Villejuif, France
Charité - Universitätsmedizin Berlin (CBF) - Hindenburgdamm 30 — Berlin, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden — Dresden, Germany
Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis — Amsterdam, Netherlands
Chungbuk National University Hospital — Cheongju-si, South Korea
CHA Bundang Medical Center, CHA University — Seongnam-si, South Korea
Seoul National University Hospital — Seoul, South Korea
START - Rioja Hospital Universitario San Pedro — Logroño, La Rioja, Spain
Hospital Regional Universitario de Malaga - Hospital General — Málaga, Malaga, Spain
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON — Barcelona, Spain
Hospital Universitario Ramon y Cajal — Madrid, Spain
Hospital Universitario Virgen del Rocio — Seville, Spain
National Taiwan University Hospital — Taipei, Taiwan
Taipei Veterans General Hospital — Taipei, Taiwan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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