NMIBCPhase 1/2NCT07445308
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.
A Phase 1/2 study testing SPGL008 in people with NMIBC, run by Shenyang Sunshine Pharmaceutical Co., LTD..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NMIBC
- What is being tested?
- SPGL008
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 12 Mar 2026to 21 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- NMIBC
- Being tested
- SPGL008
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPGL008Biological
Biological product
| Study group | Role | What they receive |
|---|---|---|
| SPGL008 | Experimental | 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 Receives: Biological: SPGL008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Measured: Approximately 2years
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.
Measured: 7 days
Recommended Phase 2 dose (RP2D)
Measured: Approximately 2 years.
CR Rate (cohort A)
Measured: Approximately 4 years.
12-month DFS Rate (cohort B/C)
Measured: Approximately 12 months
Secondary outcomes (5)
Treatment-Related Adverse Events as assessed by CTCAE v5.0
Measured: Approximately 4 years.
Duration of CR (DoR)
Measured: Approximately 4 years.
DFS
Measured: Approximately 4 years.
Time to cystectomy
Measured: Approximately 4 years.
Radical cystectomy rate
Measured: Approximately 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start12 Mar 2026 (estimated)
- Primary completion21 Nov 2028 (estimated)
- Study completion21 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMIBCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445308
- Sponsor's protocol ID
- SPGL008-102
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07445308
- Acronym / sponsor ID
- SPGL008-102
- Conditions
- NMIBC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.
- Study start
- 12 Mar 2026 (estimated)
- Primary completion
- 21 Nov 2028 (estimated)
- Study completion
- 21 Dec 2029 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPGL008 | Experimental | Biological: SPGL008Phase 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPGL008Biological product | Biological | SPGL008 |
Primary outcome
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
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SPGL008 in people with NMIBC, run by Shenyang Sunshine Pharmaceutical Co., LTD..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zhisong he (13910688432, wyj7074@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: Approximately 2years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.