Trials / Recruiting
RecruitingNCT06043817
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 251 (estimated)
- Sponsor
- Pierre Fabre Medicament · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | STX-721/PFL-721 (Escalated) | STX-721/PFL-721 dose will be escalated per cBLRM-design. |
| DRUG | STX-721/PFL-721 (3 dose levels) | Participants will receive STX-721/PFL-721 at one of three dose levels. |
| DRUG | STX-721/PFL-721 (RP2D) | Participants will receive the RP2D of STX-721/PFL-721. |
Timeline
- Start date
- 2023-09-26
- Primary completion
- 2029-12-01
- Completion
- 2029-12-01
- First posted
- 2023-09-21
- Last updated
- 2026-02-20
Locations
24 sites across 7 countries: United States, France, Germany, Netherlands, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06043817. Inclusion in this directory is not an endorsement.