Description for experts
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safetyexpansion of selected doses, and a Phase 2 (expansion cohorts)
Description for laymen
The study consists of two main parts to explore the recommended dosing of BGB-16673: a phase 1 to determine the monotherapy dose, which consists of an escalation of the monotherapy dose and an extension of the monotherapy safety of selected doses, and a phase 2 (extension cohorts).
JSON Data
{
"short_title": "Beigene BGB-16673",
"data_mode": "900",
"data_mode_number": "000002344",
"official_title": "A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "not_applicable",
"ctgov_number": "NCT05006716",
"eudract_number": "2022-502157-33",
"general_contact_email": "ectu@ukdd.de",
"general_contact_phone": "+49 351-4587566",
"hauptpruefer_dd_name": "Prof. Dr. med. Johannes Schetelig",
"description_laie_de": "Die Studie besteht aus zwei Hauptteilen, um die empfohlene Dosierung von BGB-16673 zu erforschen: eine Phase 1 zur Ermittlung der Monotherapie-Dosis, die aus einer Eskalation der Monotherapie-Dosis und einer Erweiterung der Monotherapie-Sicherheit ausgew\u00e4hlter Dosen besteht, und eine Phase 2 (Erweiterungskohorten).",
"description_laie_en": "The study consists of two main parts to explore the recommended dosing of BGB-16673: a phase 1 to determine the monotherapy dose, which consists of an escalation of the monotherapy dose and an extension of the monotherapy safety of selected doses, and a phase 2 (extension cohorts).",
"description_expert_de": "Die Studie besteht aus zwei Hauptteilen, um die empfohlene Dosierung von BGB-16673 zu erforschen: eine Phase 1 zur Ermittlung der Monotherapie-Dosis, die aus einer Eskalation der Monotherapie-Dosis und einer Erweiterung der Monotherapie-Sicherheit ausgew\u00e4hlter Dosen besteht, und eine Phase 2 (Erweiterungskohorten).",
"description_expert_en": "Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safetyexpansion of selected doses, and a Phase 2 (expansion cohorts)",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "I_II",
"main_cat_id": 4,
"sub_cat_id": 27
}
