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
NCT ID: NCT06043817
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
251 participants
INTERVENTIONAL
2023-09-26
2029-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose Escalation
STX-721/PFL-721 (Escalated)
STX-721/PFL-721 dose will be escalated per cBLRM-design.
Part 2: RP2D Selection
STX-721/PFL-721 (3 dose levels)
Participants will receive STX-721/PFL-721 at one of three dose levels.
Part 3: Dose Expansion
STX-721/PFL-721 (RP2D)
Participants will receive the RP2D of STX-721/PFL-721.
Interventions
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STX-721/PFL-721 (Escalated)
STX-721/PFL-721 dose will be escalated per cBLRM-design.
STX-721/PFL-721 (3 dose levels)
Participants will receive STX-721/PFL-721 at one of three dose levels.
STX-721/PFL-721 (RP2D)
Participants will receive the RP2D of STX-721/PFL-721.
Eligibility Criteria
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Inclusion Criteria
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 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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Locations
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City of Hope
Duarte, California, United States
City of Hope
Huntington Beach, California, United States
City of Hope
Irvine, California, United States
Levine Cancer Institute - Charlotte
Charlotte, North Carolina, United States
Thomas Jefferson University Research Facility
Philadelphia, Pennsylvania, United States
SCRI Oncology Partners - PPDS
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Utah - Huntsman Cancer Institute - PPDS
Salt Lake City, Utah, United States
NEXT Virginia
Fairfax, Virginia, United States
EDOG Institut de Cancerologie de l'Ouest - PPDS
Saint-Herblain, Loire-Atlantique, France
Institut Claudius Regaud - PPDS
Toulouse, , France
Gustave Roussy
Villejuif, , France
Charité - Universitätsmedizin Berlin (CBF) - Hindenburgdamm 30
Berlin, , Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, , Germany
Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, , Netherlands
Chungbuk National University Hospital
Cheongju-si, , South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, , South Korea
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Malaga, Spain
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Claire FABRE, Head of clinical development, MD, PhD
Role: CONTACT
Other Identifiers
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STX-721-101/PFL-721CI101
Identifier Type: -
Identifier Source: org_study_id
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