RightFit
RecruitingPhase 1 / Phase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests STX-721/PFL-721 in people with advanced non-small cell lung cancer that has certain EGFR or HER2 gene changes. Researchers will study its safety, how the body handles it, and whether it helps fight the cancer. This is the first study of this drug in humans.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old when signing the consent form.
  • Have non-small cell lung cancer confirmed by tissue or cell testing. It must be stage IIIB, IIIC, or IV and not treatable with surgery or chemotherapy plus radiation aimed at a cure.
  • Have an EGFR or HER2 exon 20 insertion, a specific gene change, confirmed by a qualified lab. Part 1 requires testing of tumor tissue.
  • For Part 1, have received all approved treatments for advanced lung cancer or be unable to receive them. For Parts 2 and 3, have received 1 or 2 prior courses of approved treatment, including platinum-based chemotherapy unless it is unsafe for you.
  • Have scans showing that the cancer has grown or spread.
  • Have a new or recent tumor sample, or a stored sample from the past 10 years, available for gene testing.
  • Have at least one tumor that can be measured using the study's rules.
  • Be fully active or able to do light work despite limits on hard physical activity (ECOG score 0 or 1).

Who can't join

  • Have the specific EGFR gene change p.H773_V774insH, or an EGFR kinase-domain activating change together with T790M or C797S resistance changes.
  • Have had another type of cancer, different from this lung cancer, within 2 years before screening.
  • Have cancer that has spread to the brain or spine and causes symptoms.
  • Have side effects from earlier cancer treatment that have not returned to your usual level or become mild. Hair loss and nerve damage outside the brain and spinal cord are exceptions.
  • Have any condition that the study doctor believes could make joining unsafe or interfere with the study's tests.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (9)

CA

NC

PA

TN

TX

UT

VA