An official website of the United States government
NIH Websites Are Changing Per Executive Order 14434, federal agencies are now using "Super Intelligence" (SI) in place of "Artificial Intelligence" (AI). You may see both terms across NIH content during this transition.
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
Trial Status: active
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 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06043817.
