Informations générales (source: ClinicalTrials.gov)
First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
Interventional
Phase 1/Phase 2
Antares Therapeutics, Inc (Voir sur ClinicalTrials)
septembre 2023
juin 2028
07 août 2025
Study STX-721-101 is an open label, Phase 1/2 study evaluating the safety, tolerability,
pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721 in
participants with non-small cell lung cancer (NSCLC) carrying EGFR/HER2 exon 20 insertion
(ex20ins) mutations.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| EDOG Institut de Cancerologie de l'Ouest - PPDS - 44115 - Saint-Herblain - Loire-Atlantique - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud - PPDS - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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 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
Key
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 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
Key
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