1. Dose escalation phase to evaluate DLT incidence (Time Frame - approximately 1 year after study start): Dose Limited Toxicity
2. Incidence and severity of treatment related adverse events (Time Frame - approximately 2.5 years after study start): Incidence and severity of treatment related adverse events during intravesical instillation with catumaxomab are observed according to NCI CTCAE, Version 5.0
Secondary outcome:
1. Anti-drug antibodies (ng/ml) (Time Frame - approximately 2.5 years after study start): the incidence of ADA (anti-drug antibodies to catumaxomab by intravesical instillation in serum
2. Cytokines (pg/mL) (Time Frame - approximately 2.5 years after study start): cytokines (pg/mL)
3. Number of EpCAM-positive tumor cells in the urine (Time Frame - approximately 2.5 years after study start): • number of EpCAM-positive tumor cells in the urine
4. Number of immune cells in the urine (Time Frame - approximately 2.5 years after study start): • number of immune cells in the urine
5. Cmax (ng/ml) (Time Frame - approximately 2.5 years after study start): PK parameter of Catumaxomab is Cmax (ng/ml)
6. Cmin (ng/ml) (Time Frame - approximately 2.5 years after study start): PK parameters of Catumaxomab is Cmin (ng/ml)
7. Tmax (hours) (Time Frame - approximately 2.5 years after study start): PK parameter of Catumaxomab is Tmax (hours)
8. AUC (day * ng/ml) (Time Frame - approximately 2.5 years after study start): PK parameters of Catumaxomab AUC (day * ng/ml)
9. t1/2 (days) (Time Frame - approximately 2.5 years after study start): PK parameter of Catumaxomab t1/2 (days)
10. Antitumor activity (Time Frame - approximately 2.5 years after study start): antitumor activities is assessed by cystoscopy and biopsy/or resection at EoT (day 43) and all follow up visits and measures and documents tumor size, tumor localization, tumor numbers and morphological criteria
11. Complete response (Time Frame - approximately 2.5 years after study start): Complete response will be defined as no histological evidence of disease at 3-monthly evaluations
12. Recurrence-free interval (Time Frame - approximately 2.5 years after study start): recurrence-free interval is evaluated following the catumaxomab treatment in the follow up phase 3 month to 2 years
13. Local progression free interval (Time Frame - approximately 2.5 years after study start): local progression free interval is evaluated following the catumaxomab treatment in the follow up phase 3 month to 2 years
14. Identification and quantification of tumor cells in urine (Time Frame - approximately 2.5 years after study start): this is evalulated at screening and in the course of the study
15. EpCAM expression (Time Frame - approximately 2.5 years after study start): Evaluation of potential and predictive EpCAM expression and relative Lymphocytes count can be correlated with outcome
Catumaxomab: Procedure: 6 weekly intravesical administration at each dose level; 3 sequential cohorts consisting of 3 patients (part I)
cohort 50 µg
cohort 70 µg
cohort 100 µg
Part II will be treated at recommended dose
Quelle: ClinicalTrials.gov
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"Investigation of Safety and Tolerability of Catumaxomab in Patients With NMIBC"
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