NCT07445308Not yet recruitingPhase 1/2
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.
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
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 5 Feb 2026
- Start date
- 12 Mar 2026
- Primary completion date
- 21 Nov 2028
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Diseases
- Bladder cancer
- NCT number
- NCT07445308
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 120
- From 12 Mar 2026 to the primary completion date, 21 Nov 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- Patients who discontinued treatment due to adverse reactions such as toxemia, systemic infection or urinary incontinence during previous BCG treatment
Other illness
- Obvious urinary tract infections and gross hematuria, indicating safety issues assessed by the investigators;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.