CARTI Cancer Center 72205 Little Rock United StatesRekrutierend» Google-Maps Ansprechpartner: Kelsey Williams E-Mail: kelsey.williams@carti.com» Ansprechpartner anzeigenCity of Hope 91010 Duarte United StatesRekrutierend» Google-Maps Ansprechpartner: Jennifer Simpson E-Mail: jsimpson@coh.org» Ansprechpartner anzeigenProvidence Saint John's Cancer Institute 90404 Santa Monica United StatesRekrutierend» Google-Maps Ansprechpartner: Kelly Garver E-Mail: kelly.garver@providence.org» Ansprechpartner anzeigen
Memorial Sloan Kettering Cancer Center 10065 New York United StatesRekrutierend» Google-Maps Ansprechpartner: Sonya Brisbane E-Mail: brisbas@mskcc.org» Ansprechpartner anzeigenUT Southwestern Medical Center 75390 Dallas United StatesRekrutierend» Google-Maps Ansprechpartner: Vida Rhodes E-Mail: vida.rhodes@utsouthwestern.edu» Ansprechpartner anzeigenUniversity of Washington 98109 Seattle United StatesRekrutierend» Google-Maps Ansprechpartner: Elsa Roberts, MD E-Mail: erobert3@fredhutch.org» Ansprechpartner anzeigenMacquarie University Hospital 2109 Macquarie Park AustraliaRekrutierend» Google-Maps Ansprechpartner: Harrison O'Brien E-Mail: harrison.obrien@mq.edu.au» Ansprechpartner anzeigenPrincess Alexandra Hospital Woolloongabba AustraliaRekrutierend» Google-Maps Ansprechpartner: Maria Vatca E-Mail: maria.vatca@tri.edu.au» Ansprechpartner anzeigenRoyal Adelaide Hospital 5000 Adelaide AustraliaRekrutierend» Google-Maps Ansprechpartner: Jesikah Logan E-Mail: jesikah.logan@sa.gov.au» Ansprechpartner anzeigenOlivia Newton-John Cancer Research Insititute 3084 Heidelberg AustraliaNoch nicht rekrutierend» Google-Maps Ansprechpartner: Tina Chen E-Mail: tina.chen@austin.org.au» Ansprechpartner anzeigenPeter MacCallum Cancer Centre Melbourne AustraliaRekrutierend» Google-Maps Ansprechpartner: Leeanne Pasanen E-Mail: leeanne.pasanen@petermac.org» Ansprechpartner anzeigenUniversity Hospitals Leuven Leuven BelgiumRekrutierend» Google-MapsRadboud University Medical Center 6525 Nijmegen NetherlandsRekrutierend» Google-Maps Ansprechpartner: Michel de Groot E-Mail: michel.degroot@radboudumc.nl» Ansprechpartner anzeigenLeiden University Medical Center Leiden NetherlandsRekrutierend» Google-MapsLausanne University Hospital Lausanne SwitzerlandRekrutierend» Google-MapsNorthern Centre for Cancer Care and Newcastle University Newcastle Upon Tyne United KingdomRekrutierend» Google-Maps
1. Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 tomography/computed tomography (PET/CT) (Time Frame - Baseline to at least 24 or 27 weeks after the start of IOT, depending on treatment schedule.): Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 from 3 (or up to 3) consecutive imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.
Secondary outcome:
1. Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI) (Time Frame - Baseline to at least 24 or 27 weeks after the start IOT, depending on treatment schedule.): Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.
2. Incidence and severity of AEs (Time Frame - Up to 48 weeks or end of treatment.): Incidence and severity of AEs
3. Incidence and severity of infusion or injection reactions (Time Frame - 33 days post infusion): Incidence and severity of infusion or injection reactions reported during or shortly after administration of the investigational product.
4. Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs (Time Frame - Up to 48 weeks or end of treatment): Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs
5. 12-lead ECG ventricular rate (bpm) (Time Frame - baseline to 48 weeks or end of study): Ventricular rate (bpm) will be recorded from the 12-lead ECG
6. 12-lead ECG PR interval (msec) (Time Frame - baseline to 48 weeks or end of study): PR interval (msec) will be recorded from the 12-lead ECG
7. 12-lead ECG QRS interval (msec) (Time Frame - baseline to 48 weeks or end of study): QRS interval (msec) will be recorded from the 12-lead ECG
8. 12-lead ECG QT interval (msec) (Time Frame - baseline to 48 weeks or end of study): QT interval (msec) will be recorded from the 12-lead ECG
9. 12-lead ECG QTc interval (msec) (Time Frame - baseline to 48 weeks or end of study): QTc interval (msec) will be recorded from the 12-lead ECG
10. 12-lead ECG Overall Result (Time Frame - baseline to 48 weeks or end of study): Investigator's overall assessment of the ECG reading will be recorded as normal or abnormal. If abnormal, as either "not clinically significant" or "clinically significant"
11. Anti-drug antibody (Time Frame - baseline to 48 weeks or end of study): Detection of anti-drug antibodies
12. Change in blood AST levels (U/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.): Blood AST levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
13. Change in blood ALT levels (U/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.): Blood ALT levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
14. Change in blood ALP levels (U/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.): Blood ALP levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
15. Change in blood bilirubin levels (mg/dL) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.): Blood bilirubin levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
16. Change in blood LDH levels (U/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.): Blood LDH levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
17. Change in blood BUN levels (mg/dL) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.): Blood BUN levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
18. Change in blood GGT levels (U/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.): Blood GGT levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
19. Change in serum creatinine levels (mg/dL) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.): Serum creatinine levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
20. Change in blood uric acid levels (mg/dL) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.): Blood uric acid levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
21. Change in blood sodium levels (mmol/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.): Blood sodium (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
22. Change in blood potassium levels (mmol/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.): Blood potassium (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
23. Change in blood chloride levels (mmol/L) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.): Blood chloride (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
24. Change in blood glucose levels (mg/dL) from baseline. (Time Frame - Baseline through 48 weeks or end of treatment.): Blood glucose (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
zirconium Zr 89 crefmirlimab berdoxam (89Zr-Df-crefmirlimab / 89Zr-Df-IAB22M2C / ): Up to three zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion or slow bolus injection as follows: First (PETbaseline) within 14 days prior to the onset of IOT, and a second (PETEOC1) 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan (PETEOC1) should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies"
Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.
Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!