Phase I/II Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of SPGL008 as Monotherapy or in Combination With BCG in Patients With Non-Muscle-Invasive Bladder Cancer
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 120
- Primary Endpoint
- Maximum tolerated dose
Overview
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:
- Determine the recommend Phase II dose of SPGL008 Alone or in Combination With BCG.To
- Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
- •High-risk NMIBC diagnosed by previous pathological biopsy
- •ineligible or unwilling to undergo radical cystectomy;
- •The level of organ function is good.
Exclusion Criteria
- •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;
- •Obvious urinary tract infections and gross hematuria, indicating safety issues assessed by the investigators;
- •Patients who discontinued treatment due to adverse reactions such as toxemia, systemic infection or urinary incontinence during previous BCG treatment
Arms & Interventions
SPGL008
Phase I：Phase Ia and Ib： Phase Ia include SPGL008 dose escalation and expansion; Phase Ib ： SPGL008 in combination with BCG dose escalation and expansion Phase II：SPGL008 in combination with BCG dose expansion in NMIBC
Intervention: SPGL008 (Biological)
Outcomes
Primary Outcomes
Maximum tolerated dose
Time Frame: 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
Time Frame: 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)
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
Secondary Outcomes
- DFS(Approximately 4 years.)
- Time to cystectomy(Approximately 4 years.)
- Radical cystectomy rate(Approximately 4 years.)
- Treatment-Related Adverse Events as assessed by CTCAE v5.0(Approximately 4 years.)
- Duration of CR (DoR)(Approximately 4 years.)