Description for experts
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 inparticipants with non-small cell lung cancer (NSCLC) carrying EGFR/HER2 exon 20 insertion(ex20ins) mutations.
Description for laymen
The STX-721-101 study is a phase 1/2, open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) exposure and preliminary antitumor activity of STX-721 participants with non-small cell lung cancer (NSCLC) harboring EGFR/ HER2 exon 20 insertion mutations (ex20ins).
JSON Data
{
"short_title": "Scorpion STX-721-101",
"data_mode": "900",
"data_mode_number": "000002388",
"official_title": "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",
"accrual_state": "planned",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "not_applicable",
"ctgov_number": "NCT06043817",
"eudract_number": "2023-506759-51",
"general_contact_email": null,
"general_contact_phone": null,
"hauptpruefer_dd_name": "Prof. Dr. med. habil Martin Wermke",
"description_laie_de": "Bei der Studie STX-721-101 handelt es sich um eine offene Phase-1/2-Studie zur Bewertung der Sicherheit, Vertr\u00e4glichkeit, pharmakokinetischen (PK) Exposition und vorl\u00e4ufigen Antitumoraktivit\u00e4t von STX-721-Teilnehmern mit nicht-kleinzelligem Lungenkrebs (NSCLC), die EGFR/ HER2-Exon-20-Insertionsmutationen (ex20ins).",
"description_laie_en": "The STX-721-101 study is a phase 1/2, open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) exposure and preliminary antitumor activity of STX-721 participants with non-small cell lung cancer (NSCLC) harboring EGFR/ HER2 exon 20 insertion mutations (ex20ins).",
"description_expert_de": null,
"description_expert_en": "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 inparticipants with non-small cell lung cancer (NSCLC) carrying EGFR/HER2 exon 20 insertion(ex20ins) mutations.",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "I",
"main_cat_id": 10,
"sub_cat_id": 50
}
