The goal of clinical trial is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With on-Muscle-Invasive Bladder Cancer. The main questions it aims to answer are: 1. Determine the recommend Phase II dose of SPGL008 Alone or in Combination With BCG.To 2. Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Biological product
Maximum tolerated dose
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Time frame: Approximately 2years
Dose-limiting toxicity
DLT will be defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug that occurred within the 7 days of first treatment.
Time frame: 7 days
Recommended Phase 2 dose (RP2D)
Time frame: Approximately 2 years.
CR Rate (cohort A)
Time frame: Approximately 4 years.
12-month DFS Rate (cohort B/C)
Time frame: Approximately 12 months
Treatment-Related Adverse Events as assessed by CTCAE v5.0
Time frame: Approximately 4 years.
Duration of CR (DoR)
Time frame: Approximately 4 years.
DFS
Time frame: Approximately 4 years.
Time to cystectomy
Time frame: Approximately 4 years.
Radical cystectomy rate
Time frame: Approximately 4 years.
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