Tests STX-721/PFL-721 in lung cancer with EGFR or HER2 exon 20 mutations
Tests STX-721/PFL-721 in adults with lung cancer carrying EGFR or HER2 mutations.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Berlin, Dresden, Frankfurt Am Main, and Munich, GermanySee the 4 sites
- Phase
- Phase 1/2
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- Technische Universitaet DresdenDresden, GermanyTaking people
- Goethe University FrankfurtFrankfurt Am Main, GermanyTaking people
- LMU Klinikum Muenchen AöRMunich, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pierre Fabre Medicament
- Trial code
- NCT06043817EU 2023-506759-51-00
- Record updated
- 30 October 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; 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.