NMIBC
Conditions
Brief summary
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.
Interventions
BIOLOGICALSPGL008
Biological product
Sponsors
Shenyang Sunshine Pharmaceutical Co., LTD.
Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent in writing; 2. Age ≥ 18 years old, gender is not limited; 3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2; 4. Expected survival time ≥ 2 years; 5. High-risk NMIBC diagnosed by previous pathological biopsy 6. ineligible or unwilling to undergo radical cystectomy; 7. The level of organ function is good.
Exclusion criteria
1. Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study; 2. 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; 3. Previous medical history or examination suggests active tuberculosis within 1 year prior to the first dose; 4. Serious infection within 4 weeks before the first administration, or undefined fever\>38.5 ℃ during screening/before the first administration; 5. Obvious urinary tract infections and gross hematuria, indicating safety issues assessed by the investigators; 6. Patients who discontinued treatment due to adverse reactions such as toxemia, systemic infection or urinary incontinence during previous BCG treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose | Approximately 2years | MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients. |
| Dose-limiting toxicity | 7 days | 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) | Approximately 2 years. | — |
| CR Rate (cohort A) | Approximately 4 years. | — |
| 12-month DFS Rate (cohort B/C) | Approximately 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment-Related Adverse Events as assessed by CTCAE v5.0 | Approximately 4 years. |
| Duration of CR (DoR) | Approximately 4 years. |
| DFS | Approximately 4 years. |
| Time to cystectomy | Approximately 4 years. |
| Radical cystectomy rate | Approximately 4 years. |
Contacts
CONTACTzhisong he
Outcome results
None listed