Testing STX-721 for advanced lung cancer with specific mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of STX-721 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that have EGFR or HER2 exon 20 insertion mutations. It is an open-label, Phase 1/2 trial that will assess pharmacokinetics and preliminary antitumor activity of the treatment across different dose levels. Participants must have confirmed mutations and measurable tumor lesions, and they will be monitored for treatment response and side effects.

Why it matters

Who can join: the full rules

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, if feasible) or archival tumor specimen collected in the past 10 years available for genomic profiling
6. Has at least one measurable tumor lesion per RECIST v1.1
7. Is ≥18 years of age at the time of signing the ICF
8. Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Key Exclusion Criteria:

1. 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
2. Has history (within ≤2 years before screening) of solid tumor or hematological malignancy that is histologically distinct from NSCLC
3. Has symptomatic brain or spinal metastases
4. Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE Grade ≤1, except for alopecia and peripheral neuropathy
5. 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

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• City of Hope
  Huntington Beach, California, United States Recruiting
• City of Hope
  Irvine, California, United States Recruiting
• Levine Cancer Institute - Charlotte
  Charlotte, North Carolina, United States Recruiting
• Thomas Jefferson University Research Facility
  Philadelphia, Pennsylvania, United States Recruiting
• SCRI Oncology Partners - PPDS
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Adele De MASSON, clinical development director, MD, PhD
• Email: PFL721_medical.team@pierre-fabre.com
• Phone: 33 772344916

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.