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NCT Number: NCT06043817

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung EGFR/HER2 Exon 20 Insertion Mutation Lung Diseases Lung Neoplasms NSCLC Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

EDOG Institut de Cancerologie de l'Ouest - PPDS, Saint-Herblain, Loire-Atlantique, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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 approved 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

Key Exclusion Criteria:

  • 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

Treatment and study plan

STX-721/PFL-721 (Escalated)

Drug

STX-721/PFL-721 dose will be escalated per cBLRM-design.

STX-721/PFL-721 (3 dose levels)

Drug

Participants will receive STX-721/PFL-721 at one of three dose levels.

STX-721/PFL-721 (RP2D)

Drug

Participants will receive the RP2D of STX-721/PFL-721.

Primary outcomes

  1. Part 1 Dose Escalation (MTD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment

    Time frame: 28 days

  2. Part 1 Dose Escalation (OBD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment

    Time frame: 28 days

  3. Part 2 RP2D Selection: C(max) of STX-721/PFL-721

    Time frame: 1 year

  4. Part 2 RP2D Selection: AUC(0-inf) of STX-721/PFL-721

    Time frame: 1 year

  5. Part 2 RP2D Selection: AUC(0-t) of STX-721/PFL-721

    Time frame: 1 year

  6. Part 2 RP2D Selection: AUC(0-τ) of STX-721/PFL-721

    Time frame: 1 year

  7. 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.

    Time frame: 1 year

  8. 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.

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Adele De MASSON, clinical devlopment director, MD, PhD

CONTACT

[email protected]

33 772344916

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Sep 21, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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