First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastati
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.
| Condition(s) | Non-Small Cell Lung Cancer, NSCLC, EGFR/HER2 Exon 20 Insertion Mutation |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Pierre Fabre Medicament |
| Locations | Duarte, California, United States; Huntington Beach, California, United States; Irvine, California, United States; Charlotte, North Carolina, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States (+18 more sites) |
| Start date | 2023-09-26 |
| NCT ID | NCT06043817 |
| Official listing | https://clinicaltrials.gov/study/NCT06043817 |