A PHASE I/II, OPEN-LABEL, DOSE ESCALATION AND EXTENSION STUDY OF INTRAVESICAL ECISKAFUSP ALFA IN COMBINATION WITH BACILLUS CALMETTE-GUÉRIN (BCG) IN PARTICIPANTS WITH BCG-UNRESPONSIVE HIGH- RISK NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC)

BCG-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC)

Phase I: Incidence, nature, and severity of adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Phase I: Nature and frequency of dose-limiting toxicities (DLTs), Phase I: RDE to be selected based on evaluation of safety, Phase II (Cohort A): Complete response (CR) rate at 12 months

Phase I, and Phase II (Cohorts A and B): CR rate at any time, Phase I, and Phase II (Cohorts A and B): CR rate at 6, 18, and 24 months, For Phase I, and Cohort B in Phase II: CR rate at 12 months, Phase I, and Phase II (Cohorts A and B): Duration of response (DoR), Phase I, and Phase II (Cohorts A and B): DoR rate at specific time points (at 6, 12, 18, 24, 30, and 36 months)., Phase I, and Phase II (Cohorts A and B): Time to worsening of grade or stage, or death., Phase I, and Phase II (Cohorts A and B): Progression free survival (PFS) to muscle invasive or metastatic disease or death., Phase I, and Phase II (Cohorts A and B): Time to cystectomy., Phase II (Cohorts A and B): Incidence, nature, and severity of adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Phase II (Cohorts A and B): Incidence and titer of eciskafusp alfa anti-drug antibodies (ADAs) during the study relative to prevalence of ADAs at baseline (serum)., Phase II: Pre-treatment and on-treatment (as available) PD-L1 expression in the TME., Phase II: Pre-treatment CD8+ T cell prevalence., Phase II: Baseline urine tumor DNA, Phase II: On treatment vs. baseline urine tumor DNA.

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