Indikation (Clinical Trials):
Small Cell Lung Carcinoma
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 1
Sponsor:
Amgen
Collaborator:
-
Studienleiter
MD Study Director Amgen
Kontakt
Amgen Call Center Kontakt: Phone: 866-572-6436 E-Mail: medinfo@amgen.com» Kontaktdaten anzeigen
Studienlocations (3 von 39)
Universitaetsklinikum Wuerzburg 97078 Wuerzburg (Bayern) GermanyRekrutierend» Google-MapsCity of Hope National Medical Center 91010 Duarte United StatesAbgeschlossen» Google-MapsYale New Haven Hospital 06510 New Haven United StatesRekrutierend» Google-Maps
Moffitt Cancer Center 33612 Tampa United StatesAbgebrochen» Google-MapsWinship Cancer Institute 30322 Atlanta United StatesRekrutierend» Google-MapsUniversity of Chicago 60637 Chicago United StatesRekrutierend» Google-MapsOchsner Clinic Foundation 70121 New Orleans United StatesRekrutierend» Google-MapsJohn Hopkins Sidney Kimmel Comprehensive Cancer Center 21287 Baltimore United StatesRekrutierend» Google-MapsHenry Ford Health System 48202 Detroit United StatesRekrutierend» Google-MapsWashington University 63110-1093 Saint Louis United StatesRekrutierend» Google-MapsMemorial Sloan Kettering Cancer Center 10021 New York United StatesRekrutierend» Google-MapsUniversity Hospitals Cleveland Medical Center 44106 Cleveland United StatesRekrutierend» Google-MapsThe Ohio State University Wexner Medical Center - Thoracic Oncology Clinic 43210 Columbus United StatesRekrutierend» Google-MapsFox Chase Cancer Center 19111 Philadelphia United StatesRekrutierend» Google-MapsUniversity of Pittsburgh Medical Center Cancer Pavillion 15232 Pittsburgh United StatesAbgebrochen» Google-MapsSarah Cannon Research Institute 37203 Nashville United StatesRekrutierend» Google-MapsChris OBrien Lifehouse 2050 Camperdown AustraliaRekrutierend» Google-MapsMedizinische Universitaet Graz 8036 Graz AustriaRekrutierend» Google-MapsLandeskrankenhaus Salzburg 5020 Salzburg AustriaAbgebrochen» Google-MapsGustave Roussy 94805 Villejuif FranceRekrutierend» Google-MapsPrince of Wales Hospital Shatin, New Territories Hong KongRekrutierend» Google-MapsNational Cancer Center Hospital East 277-8577 Kashiwa-shi JapanRekrutierend» Google-MapsNational Cancer Center Hospital 104-0045 Chuo-ku JapanRekrutierend» Google-MapsWakayama Medical University Hospital 641-8510 Wakayama-shi JapanRekrutierend» Google-MapsNederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis 1066 CX Amsterdam NetherlandsRekrutierend» Google-MapsMaastricht Universitair Medisch Centrum 6229 HX Maastricht NetherlandsAbgeschlossen» Google-MapsBiokinetica SA 05-410 Jozefow PolandRekrutierend» Google-MapsEuropejskie Centrum Zdrowia Otwock Szpital imienia Fryderyka Chopina 05-400 Otwock PolandRekrutierend» Google-MapsHospital Universitari Vall d Hebron 08035 Barcelona SpainRekrutierend» Google-MapsHospital Clinic i Provincial de Barcelona 08036 Barcelona SpainRekrutierend» Google-MapsHospital Universitario Ramon y Cajal 28034 Madrid SpainRekrutierend» Google-MapsHospital Universitario 12 de Octubre 28041 Madrid SpainRekrutierend» Google-MapsHospital Universitario La Paz 28046 Madrid SpainRekrutierend» Google-MapsCentre Hospitalier Universitaire Vaudois 1011 Lausanne SwitzerlandRekrutierend» Google-MapsKantonsspital St Gallen 9007 Sankt Gallen SwitzerlandRekrutierend» Google-MapsKaohsiung Medical University Chung-Ho Memorial Hospital 80756 Kaohsiung TaiwanRekrutierend» Google-MapsTri-Service General Hospital 11490 Taipei TaiwanRekrutierend» Google-MapsLinkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation 33305 Taoyuan TaiwanRekrutierend» Google-MapsChristie Hospital M20 4BX Manchester United KingdomRekrutierend» Google-Maps
1. Number of participants with dose limiting toxicities (DLT) for all indications (Time Frame - 6 months)
2. Number of participants with treatment-emergent adverse events (AEs) for all indications (Time Frame - 4 years)
3. Number of participants with treatment-related AEs for all indications (Time Frame - 4 years)
4. Number of participants with clinically significant changes in vital signs for all indications (Time Frame - 4 years)
5. Number of participants with significant changes in electrocardiogram (ECG) for all indications (Time Frame - 4 years)
6. Number of participants with significant changes in physical examinations for all indications (Time Frame - 4 years)
7. Number of participants with significant changes in clinical laboratory tests for all indications (Time Frame - 4 years)
Secondary outcome:
1. Maximum observed concentration (Cmax) following intravenous administration for all indications (Time Frame - 4 years)
2. Minimum observed concentration (Cmin) following intravenous administration for all indications (Time Frame - 4 years)
3. Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications (Time Frame - 4 years)
4. Accumulation following multiple dosing for all indications (Time Frame - 4 years)
5. Half-life (t1/2) following intravenous administration for all indications (Time Frame - 4 years)
6. Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Time Frame - 4 years): Only for parts A, D, E, F, and G
7. Duration of Response (DOR) for all indications (Time Frame - 4 years)
8. Time to Response (TTR) (Time Frame - 4 years)
9. 9-month Progression-Free Survival (PFS) for all indications (Time Frame - 9 months)
10. 9-month Overall Survival (OS) for all indications (Time Frame - 9 months)
Experimental: Part C Tarlatamab with Pembrolizumab
Experimental: Part D Tarlatamab with additional CRS mitigation strategies
Experimental: Part E Tarlatamab administration with 24-hour monitoring
Experimental: Part F Tarlatamab administered in outpatient infusion centers with 8-hour monitoring
Optional wearable digital device substudy (US sites only)
Experimental: Part G Tarlatamab additional dosing schedule
Optional wearable digital device substudy (US sites only)
Tarlatamab: Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Pembrolizumab: Pembrolizumab is a potent humanized IgG4 monoclonal antibody (mAb) with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2
CRS Mitigation Strategies: Participants will be treated with one of the CRS mitigation strategies.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)"
Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.
Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!