Novartis Investigative Site 45147 Essen (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsUniversity Of California LA Santa Monica Location 90095 Los Angeles United StatesRekrutierend» Google-Maps Ansprechpartner: Lisa Zhou Phone: 310-582-4069 E-Mail: LisaZhou@mednet.ucla.edu» Ansprechpartner anzeigenFlorida Cancer Specialists Sarasota Office 33901 Fort Myers United StatesRekrutierend» Google-Maps Ansprechpartner: Erin Finch Phone: 941-377-9993 E-Mail: erin.finch@flcancer.com» Ansprechpartner anzeigen
Massachusetts General Hospital Dept. of Mass General Hospital 02114 Boston United StatesRekrutierend» Google-Maps Ansprechpartner: Justin Gainor Phone: 617-724-4000 E-Mail: jgainor@partners.org» Ansprechpartner anzeigenNovartis Investigative Site 1200 Bruxelles BelgiumRekrutierend» Google-MapsNovartis Investigative Site 75231 Paris FranceRekrutierend» Google-MapsNovartis Investigative Site 20133 Milano ItalyRekrutierend» Google-MapsNovartis Investigative Site 277 8577 Kashiwa JapanRekrutierend» Google-MapsNovartis Investigative Site 168583 Singapore SingaporeRekrutierend» Google-MapsNovartis Investigative Site 08035 Barcelona SpainRekrutierend» Google-MapsNovartis Investigative Site 10002 Taipei TaiwanRekrutierend» Google-Maps
1. Incidence and nature of Dose Limiting Toxicities (DLTs) during the DLT evaluation period for single agent QEQ278 (Time Frame - 28 days): A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT evaluation period and meets the criteria defined in the study protocol.
2. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Time Frame - Up to 31 months): Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, vital signs, and electrocardiograms (ECGs) qualifying and reported as AEs.
3. Frequency of dose interruptions, reductions (Time Frame - Up to 30 months): Number of dose interruptions of QEQ278 and number of dose reductions of QEQ278
4. Dose intensity (Time Frame - Up to 30 months): Dose intensity of QEQ278 is defined as the ratio of actual cumulative dose received and actual duration of exposure.
Secondary outcome:
1. Overall response rate (ORR) per RECIST v1.1 (Time Frame - Up to 30 months): ORR is defined as the proportion of patients with a confirmed BOR of complete response (CR) or partial response (PR) by local investigator review as per RECIST v1.1.
2. Disease control rate (DCR) per RECIST v1.1 (Time Frame - Up to 30 months): DCR is defined as the proportion of patients with a confirmed best overall response (BOR) of CR or PR or stable disease (SD) by local investigator review as per RECIST v1.1.
3. Duration of Response (DOR) per RECIST v1.1 (Time Frame - Up to 30 months): DOR is defined as the time form the date of the first documented response (CR or PR) to the date of the first documented progression by local investigator review as per RECIST v1.1 or death due to underlying cancer.
4. Progression-free survival (PFS) per RECIST v 1.1 (Time Frame - Up to 30 months): PFS is defined as the time from the date of start of treatment to the date of the first documented progression by local investigator review as per RECIST v1.1, or death due to any cause.
5. Peak serum concentration (Cmax) of QEQ278 (Time Frame - During first 168 days of treatment): The maximum (peak) serum drug concentration after single dose administration
6. Area under the concentration time curve (AUC) last of QEQ278 (Time Frame - During first 168 days of treatment): The AUC from time zero to the last measurable concentration sampling time
7. Area under the concentration time curve (AUC) infinity of QEQ278 (Time Frame - During first 168 days of treatment): The AUC from time zero to infinity
8. Time to reach peak serum concentration (Tmax) of QEQ278 (Time Frame - During first 168 days of treatment): The time to reach maximum (peak) serum drug concentration after single dose administration
9. Elimination half-life (T1/2) of QEQ278 (Time Frame - During first 168 days of treatment): The elimination half-life associated with the terminal slope of a semi logarithmic concentration-time curve
10. Total body clearance (CL) of QEQ278 (Time Frame - During first 168 days of treatment): The total body clearance of drug from the serum
11. Volume of distribution (Vz) of QEQ278 (Time Frame - During first 168 days of treatment): The apparent volume of distribution during terminal phase
12. Incidence of anti-drug antibody (ADA) (Time Frame - Day 1 and 15): Immunogenicity of QEQ278
