John Mei Kontakt: Phone: 650-542-0136 E-Mail: jmei@kartosthera.com» Kontaktdaten anzeigen Emily Houlihan Kontakt: Phone: 401-954-8042 E-Mail: ehoulihan@kartosthera.com» Kontaktdaten anzeigen
Studienlocations (3 von 51)
Vivantes Network for Health Gmb, Neukölln Clinic Berlin (Berlin) GermanyRekrutierend» Google-MapsHautkrebszentrum Universitätsklinikum Erlangen Ulmenweg 18 91054 Erlangen (Bayern) DeutschlandRekrutierend» Google-MapsUniversitätsklinikum Essen (AöR) Essen (Nordrhein-Westfalen) GermanyRekrutierend» Google-Maps
Nationales Centrum für Tumorerkrankungen NCT Heidelberg (Baden-Württemberg) GermanyRekrutierend» Google-MapsUniklinik Koln Köln (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsKopf-Hals-Tumor-Zentrum der Universitätsklinik Rostock Doberaner Straße 137-139 18057 Rostock DeutschlandRekrutierend» Google-MapsUniversitats-Hautklinik Tubingen Tübingen (Baden-Württemberg) GermanyRekrutierend» Google-MapsUniversity of Colorado Anschutz Medical Campus 80045 Aurora United StatesRekrutierend» Google-MapsMiami Cancer Institute 33176 Miami United StatesRekrutierend» Google-MapsMoffitt 33612 Tampa United StatesRekrutierend» Google-MapsNorthwestern Memorial Hospital 60612 Chicago United StatesRekrutierend» Google-MapsNorton Healthcare 40202 Louisville United StatesRekrutierend» Google-Maps Ansprechpartner: Norton Cancer Institute Research» Ansprechpartner anzeigenMassachusetts General Hospital 02114 Boston United StatesRekrutierend» Google-MapsDana-Farber Cancer Institute 02215-5418 Boston United StatesRekrutierend» Google-MapsUniversity of Michigan 48109 Ann Arbor United StatesRekrutierend» Google-MapsMemorial Sloan-Kettering Cancer Center 10021 New York United StatesRekrutierend» Google-MapsMount Sinai Hospital 10029 New York United StatesRekrutierend» Google-MapsFox Chase Cancer Center 19111-2434 Philadelphia United StatesAktiv, nicht rekrutierend» Google-MapsUPMC Hillman Cancer Center 15232 Pittsburgh United StatesRekrutierend» Google-MapsUniversity of Texas MD Anderson 77030 Houston United StatesRekrutierend» Google-MapsInova Health Care Services 22031 Fairfax United StatesRekrutierend» Google-MapsPrincess Alexandra Hospital Oncology Woolloongabba AustraliaRekrutierend» Google-MapsCentro Catarinense de Pesquisa (CECAP) - Hospital Santa Catarina de Blumenau Blumenau BrazilRekrutierend» Google-MapsInstituto Nacional do Cancer Brasília BrazilRekrutierend» Google-MapsCentro Intergado de Oncologia Curitiba BrazilRekrutierend» Google-MapsCentro de Pesquisa Clinica em Oncologia Ijuí BrazilRekrutierend» Google-MapsClinica De Neoplasias Litoral Itajai BrazilRekrutierend» Google-MapsHospital Paulistano São Paulo BrazilRekrutierend» Google-MapsPrincess Margaret Cancer Centre Toronto CanadaRekrutierend» Google-MapsCHU de Bordeaux- Hopital Saint-Andre Bordeaux FranceRekrutierend» Google-MapsAP-HP Universite Paris Saclay Gif-sur-Yvette FranceRekrutierend» Google-MapsCHU de Lille Lille FranceRekrutierend» Google-MapsCHU Lyon-Sud Lyon FranceRekrutierend» Google-MapsHôpital de la Timone. Aix-Marseille Université Cedex 5 Marseille FranceRekrutierend» Google-MapsCHU Montpellier Montpellier FranceRekrutierend» Google-MapsCHU de Nantes Nantes FranceRekrutierend» Google-MapsHôpital Saint Louis - APHP Paris FranceRekrutierend» Google-MapsCHU de Tours Tours FranceRekrutierend» Google-MapsInstitute for Cancer Research and Treatment Candiolo ItalyRekrutierend» Google-MapsIstituto Nazionale Tumori IRCCS Fondazione Pascale Napoli ItalyRekrutierend» Google-MapsAUSL della Romagna Ravenna ItalyRekrutierend» Google-MapsAOUS Le Scotte Siena ItalyRekrutierend» Google-MapsOSP Civile Maggiore Borgo Trento Verona ItalyRekrutierend» Google-MapsNational Cancer Center Goyang-si Korea, Republic ofRekrutierend» Google-MapsSeoul National University Hospital Seoul Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital Yonsei University Health System Seoul Korea, Republic ofRekrutierend» Google-MapsUniversity Medical Center Groningen Groningen NetherlandsRekrutierend» Google-MapsHospital Duran i Reynals Barcelona SpainRekrutierend» Google-MapsHospital General Universitario Gregorio Marañn (Madrid) Madrid SpainRekrutierend» Google-MapsComplejo Hospitalario de Navarra Pamplona SpainRekrutierend» Google-MapsFundacio Investigao Hospital General Universitario de Valencia Valencia SpainRekrutierend» Google-Maps
1. Cohort 1 Part 1: To determine the KRT-232 RP2D. (Time Frame - 10 Weeks): The Safety Review Committee (SRC) will determine RP2D for expansion based on safety and tolerability of each arm.
2. Cohort 1 Part 2: To determine the objective response rate (ORR) in subjects with p53WT MCC who have failed anti-PD-1 or anti-PDL-1 immunotherapy (Time Frame - 10 Weeks): ORR will be assessed per RECIST criteria version 1.1 after all subjects have been treated at the RP2D of KRT 232 and completed the second response assessment.
3. Cohort 2 Part 1: To determine the KRT-232 RP2D in combination with avelumab (Time Frame - 28 Days): DLTs will be used to establish the MTD of KRT-232 in combination with avelumab. SRC will determine the RP2D based on the safety of combination of KRT-232 with avelumab.
4. Cohort 2 Part 2: To determine the objective response rate (ORR) in treatment-naïve subjects with p53WT MCC (Time Frame - 10 Weeks): ORR will be assessed per RECIST criteria version 1.1 after all 30 subjects have been treated at the RP2D of in combination with avelumab and have completed the second response assessment.
5. Cohort 3: To determine the confirmed overall response rate (ORR) based on IRC assessments in subjects with p53WT MCC are chemotherapy naive and have failed anti-PD-1/PD-L. (Time Frame - 10 Weeks): ORR will be assessed per RECIST criteria 1.1 by IRC.
6. Cohort 4: To determine the confirmed overall response rate (ORR) based on IRC assessments in subjects with p53WT MCC who have failed anti-PD-1 or anti-PDL-1 immunotherapy and have had least 1 line of prior chemotherapy. (Time Frame - 10 Weeks): ORR will be assessed per RECIST criteria 1.1 by IRC.
Secondary outcome:
1. To determine the confirmed ORR based on investigator assessment. (Time Frame - 1 year after last subject enrolled.): ORR will be assessed per RECIST criteria 1.1 by investigators.
2. To determine the duration of response (DoR) (Time Frame - 1 year after last subject enrolled): Time from documentation of response (CR or PR as determined by RECIST 1.1) until disease progression.
3. To determine Progression-free survival (PFS) (Time Frame - 1 year after last subject enrolled): Time from initial treatment until disease progression.
4. To determine overall survival (OS) (Time Frame - 1 year after last subject enrolled): Time from initial treatment until death from any cause.
5. To determine clinical benefit rate (CBR) (Time Frame - 1 year after last subject enrolled.): PR, CR or stable disease that last at least 10 weeks, per IRC or investigator assessment.
Experimental: Cohort 1, Arm 1 KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 21-day cycle.
Experimental: Cohort 1, Arm 1b KRT-232 will be administered orally, once daily (QD) on Days 1-5 in a 23-day cycle.
Experimental: Cohort 1, Arm 2b KRT-232 will be administered orally, once daily (QD) on Days 1-5 in a 28-day cycle.
Experimental: Cohort 1, Arm 3 KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 21-day cycle.
Experimental: Cohort 1, Arm 5 KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle.
Experimental: Cohort 1 Expansion KRT-232 will be administered orally, once daily (QD) per Cohort 1 RP2D dose and schedule.
Experimental: Cohort 2, Arm 1 KRT-232 in combination with avelumab KRT-232 will be administered orally, once daily (QD) on Days 1-5, in combination with avelumab 800 mg IV on Day 1 and 15 in a 28-day cycle.
Experimental: Cohort 2, Arm 2 KRT-232 in combination with avelumab KRT-232 will be administered orally, once daily (QD) on Days 1-7, in combination with avelumab 800 mg IV on Day 1 and 15 in a 28-day cycle.
Experimental: Cohort 2 Expansion KRT-232 will be administered orally, once daily (QD) per RP2D dose and schedule, in combination with avelumab 800 mg IV on Day 1 and 15 in a 28-day cycle.
Experimental: Cohort 3 KRT-232 will be administered orally, once daily (QD) per Cohort 1 RP2D dose and schedule.
Experimental: Cohort 4 KRT-232 will be administered orally, once daily (QD) per Cohort 1 RP2D dose and schedule.