RecruitingPhase 1Phase 2NCT06043817
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
Sponsor
Pierre Fabre Medicament
Enrollment
251 participants
Start Date
Sep 26, 2023
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 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 Criteria5
- 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
Interventions
DRUGSTX-721/PFL-721 (Escalated)
STX-721/PFL-721 dose will be escalated per cBLRM-design.
DRUGSTX-721/PFL-721 (3 dose levels)
Participants will receive STX-721/PFL-721 at one of three dose levels.
DRUGSTX-721/PFL-721 (RP2D)
Participants will receive the RP2D of STX-721/PFL-721.
Locations(24)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06043817