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Recruiting 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

Phase I / Phase II Interventional Non-Small Cell Lung Cancer NSCLC EGFR/HER2 Exon 20 Insertion Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: STX-721/PFL-721 (Escalated), STX-721/PFL-721 (3 dose levels), STX-721/PFL-721 (RP2D).
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer, NSCLC, EGFR/HER2 Exon 20 Insertion Mutation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France, Germany, Netherlands, South Korea +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
  • 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]
  • Part 2 RP2D Selection: C(max) of STX-721/PFL-721 [Time frame: 1 year]
  • Part 2 RP2D Selection: AUC(0-inf) of STX-721/PFL-721 [Time frame: 1 year]
  • Part 2 RP2D Selection: AUC(0-t) of STX-721/PFL-721 [Time frame: 1 year]
  • Part 2 RP2D Selection: AUC(0-τ) of STX-721/PFL-721 [Time frame: 1 year]
  • 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]
  • 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]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 9 centers
  • City of Hope — Duarte
  • City of Hope — Huntington Beach
  • City of Hope — Irvine
  • Levine Cancer Institute - Charlotte — Charlotte
  • Thomas Jefferson University Research Facility — Philadelphia
  • SCRI Oncology Partners - PPDS — Nashville
  • University of Texas MD Anderson Cancer Center — Houston
  • University of Utah - Huntsman Cancer Institute - PPDS — Salt Lake City
  • … and 1 more center
Spain · 4 centers
  • Hospital Regional Universitario de Malaga - Hospital General — Málaga
  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON — Barcelona
  • Hospital Universitario Ramon y Cajal — Madrid
  • Hospital Universitario Virgen del Rocio — Seville
France · 3 centers
  • EDOG Institut de Cancerologie de l'Ouest - PPDS — Saint-Herblain
  • Institut Claudius Regaud - PPDS — Toulouse
  • Gustave Roussy — Villejuif
South Korea · 3 centers
  • Chungbuk National University Hospital — Cheongju-si
  • CHA Bundang Medical Center, CHA University — Seongnam-si
  • Seoul National University Hospital — Seoul
Germany · 2 centers
  • Charité - Universitätsmedizin Berlin (CBF) - Hindenburgdamm 30 — Berlin
  • Universitätsklinikum Carl Gustav Carus an der TU Dresden — Dresden
Taiwan · 2 centers
  • National Taiwan University Hospital — Taipei
  • Taipei Veterans General Hospital — Taipei
Netherlands · 1 center
  • Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis — Amsterdam

Identifiers

NCT: NCT06043817 · STX-721-101/PFL-721CI101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗