The Study is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With NMIBC, and to Determine the RP2D of SPGL008 Alone or in Combination With BCG.To Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SPGL008.
- Who it may be relevant to
- Registry conditions: NMIBC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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
- Biological SPGL008
Biological product
Primary outcome measures
- Maximum tolerated dose [Time frame: Approximately 2years]
- Dose-limiting toxicity [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]
Secondary outcome measures (5)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07445308 · SPGL008-102