Actively Recruiting
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
Led by Pierre Fabre Medicament · Updated on 2026-04-24
251
Participants Needed
24
Research Sites
322 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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 Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of NSCLC Stage IIIB/C or IV not eligible for curative surgery or chemoradiation
- EGFR or HER2 exon 20 insertion mutations confirmed by qualified local laboratories
- Part 1: Received all approved therapies for advanced or metastatic NSCLC or is ineligible; Parts 2 and 3: Received 1 to 2 prior lines of approved treatment for advanced/metastatic NSCLC, including at least one platinum-based chemotherapy unless contraindicated
- Documented tumor progression based on imaging
- New or recent tumor biopsy at screening if feasible, or archival tumor specimen collected within 10 years available for genomic profiling
- At least one measurable tumor lesion per RECIST v1.1
- At least 18 years of age at signing informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- Tumor with EGFR ex20ins p.H773_V774insH variant or any EGFR kinase domain activating mutation with T790M and/or C797S resistance mutations
- History within 2 years before screening of solid tumor or blood cancer distinct from NSCLC
- Symptomatic brain or spinal metastases
- Unresolved toxicities from prior anticancer therapies except alopecia and peripheral neuropathy
- Any condition that investigator feels would put participant's well-being at risk or interfere with study assessments
AI-Screening
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Trial Site Locations
Total: 24 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope
Huntington Beach, California, United States, 92648
Actively Recruiting
3
City of Hope
Irvine, California, United States, 92618
Actively Recruiting
4
Levine Cancer Institute - Charlotte
Charlotte, North Carolina, United States, 28204-2990
Actively Recruiting
5
Thomas Jefferson University Research Facility
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
6
SCRI Oncology Partners - PPDS
Nashville, Tennessee, United States, 37203
Actively Recruiting
7
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Actively Recruiting
8
University of Utah - Huntsman Cancer Institute - PPDS
Salt Lake City, Utah, United States, 84112-5550
Actively Recruiting
9
NEXT Virginia
Fairfax, Virginia, United States, 22031-2171
Actively Recruiting
10
EDOG Institut de Cancerologie de l'Ouest - PPDS
Saint-Herblain, Loire-Atlantique, France, 44115
Actively Recruiting
11
Institut Claudius Regaud - PPDS
Toulouse, France, 31059
Actively Recruiting
12
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
13
Charité - Universitätsmedizin Berlin (CBF) - Hindenburgdamm 30
Berlin, Germany, 12203
Actively Recruiting
14
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Germany, 01307
Actively Recruiting
15
Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066
Actively Recruiting
16
Chungbuk National University Hospital
Cheongju-si, South Korea, 28644
Actively Recruiting
17
CHA Bundang Medical Center, CHA University
Seongnam-si, South Korea, 13496
Actively Recruiting
18
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
19
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Malaga, Spain, 29010
Actively Recruiting
20
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, Spain, 8035
Actively Recruiting
21
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
22
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
23
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
24
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
Research Team
A
Adele De MASSON, clinical devlopment director, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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