First-In-Human Study of STX-721/PFL-721 for NSCLC with EGFR or HER2 Exon 20 Insertion Mutations
This study is testing a new drug called STX-721/PFL-721 for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific changes (mutations) in the EGFR or HER2 genes, called exon 20 insertion mutations. The main goals are to find a safe dose of STX-721/PFL-721 and see how well your body handles it. Researchers will also look for early signs of the drug's effectiveness against cancer. To join, you must have NSCLC that has spread or is advanced, and your tumor must have these specific EGFR or HER2 exon 20 insertion mutations. The study is currently unclear on its recruitment status and plans to enroll 345 participants.
- Study design
- This is an open-label study, meaning both you and your doctors will know which treatment you are receiving. It is a Phase 1/2 study, which means it's an early-stage trial looking at safety and initial effectiveness, and plans to enroll 345 participants.
- What's involved
- Participants will receive STX-721/PFL-721 at different dose levels. The study will measure how many participants experience side effects within the first 28 days of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The concentration of STX-721/PFL-721 in your body will be measured for up to 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
Where it's being run
24 sites across 15 statesWho to contact
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What this trial measures
- Part 1 Dose Escalation (MTD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment28 days
- Part 1 Dose Escalation (OBD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment28 days
- Part 2 RP2D Selection: C(max) of STX-721/PFL-7211 year
- Part 2 RP2D Selection: AUC(0-inf) of STX-721/PFL-7211 year
- Part 2 RP2D Selection: AUC(0-t) of STX-721/PFL-7211 year
- Part 2 RP2D Selection: AUC(0-τ) of STX-721/PFL-7211 year
- Part 2 RP2D Selection: Number of participants with confirmed objective response rate (ORR) defined as the percentage of participants with partial response (PR) or complete response (CR) based on RECIST v1.1 per investigator assessment.1 year
- Part 3 Dose Expansion: Number of participants with confirmed ORR defined as the percentage of participants with PR or CR based on RECIST v1.1 per investigator assessment.1 year