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.
Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent in writing;
Age ≥ 18 years old, gender is not limited;
Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
Expected survival time ≥ 2 years;
Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study;
Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;
Previous medical history or examination suggests active tuberculosis within 1 year prior to the first dose;
Serious infection within 4 weeks before the first administration, or undefined fever>38.5 ℃ during screening/before the first administration;
Single group
SPGL008
Biological/VaccineBiological product
Maximum tolerated dose
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
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.
Recommended Phase 2 dose (RP2D)
CR Rate (cohort A)
Treatment-Related Adverse Events as assessed by CTCAE v5.0
Duration of CR (DoR)
DFS
Time to cystectomy
Click on the lead sponsor to view all of their trials.
Shenyang Sunshine Pharmaceutical Co., LTD.
Lead sponsor
Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
