High-risk Non-muscle-invasive Bladder CancerPhase 1/2NCT07468851
A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy
A Phase 1/2 study testing HS-10566 in people with High-risk Non-muscle-invasive Bladder Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This is a multicenter, open-label, Phase I/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder cancer who are ineligible for or refuse radical cystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-risk Non-muscle-invasive Bladder Cancer
- What is being tested?
- HS-10566
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesChina
- Study dates
- 5 Aug 2026to 30 Apr 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
- Men or women aged greater than or equal to (≥) 18 years.
- Signed informed consent form.
- Histologically confirmed non-muscle-invasive bladder urothelial carcinoma (i.e., transitional cell carcinoma). Mixed tumor types predominantly consisting of urothelial carcinoma are eligible. Patients diagnosed with neuroendocrine, micropapillary, signet-ring cell, plasmacytoid, or sarcomatoid features are excluded.
- Patients with non-muscle-invasive bladder cancer (NMIBC) who have undergone prior transurethral resection of bladder tumor (TURBT) and who refuse or are ineligible for radical cystectomy, and meet one of the following two populations:
- Patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy after prior TURBT, and who refuse or are ineligible for radical cystectomy. BCG unresponsive is defined as occurrence of any one of the following in NMIBC patients after adequate BCG therapy (at least 5 full dose inductions and at least 2 maintenance instillations of BCG):
- Persistent or recurrent CIS within 12 months after adequate BCG therapy, with or without recurrence of high-grade Ta or T1 tumors;
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- Recurrence of high-grade Ta/T1 tumors within 6 months after adequate BCG therapy;
- Recurrence of high-grade T1 tumors at the first assessment during maintenance therapy after BCG induction.
- Patients who have not received BCG therapy after prior TURBT, including the following three scenarios:
- NMIBC patients who failed intravesical chemotherapy, and who have not received BCG.
- HR-NMIBC patients who have not received BCG therapy after TURBT.
- HR-NMIBC patients who received prior BCG therapy but discontinued treatment for more than 3 years before enrollment.
- Participants must have undergone TURBT within 12 weeks prior to signing informed consent and meet the following criteria:
- For papillary lesions (Ta and T1 stages): complete resection of all visible papillary lesions, with negative urine cytology (including atypical findings).
- For patients with CIS: residual unresectable CIS lesions are permitted.
- Sufficient bone marrow reserve and adequate hepatic/renal function.
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.
Who cannot join
- Histopathologically confirmed muscle invasive (pathologic T stage ≥ T2), locally advanced, unresectable, or metastatic urothelial carcinoma.
- Urothelial carcinoma outside the bladder (e.g., urethra, ureter, renal pelvis) unless radically resected with no disease recurrence for > 2 years.
- History of other primary solid tumors, except:
- Radically treated solid tumor with no activity for ≥5 years before enrollment and low recurrence risk;
- adequately treated non-melanoma skin cancer (e.g., basal cell carcinoma, squamous cell carcinoma) or lentigo maligna with no evidence of recurrence;
- adequately treated carcinoma in situ (e.g., cervical, ductal carcinoma in situ of breast) with no evidence of recurrence.
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- Has received or is receiving any of the following treatments:
- Regular intravesical chemotherapy (gemcitabine, pirarubicin, mitomycin, etc.) or BCG instillation intolerance following TURBT/bladder biopsy before enrollment.
- Pelvic radiotherapy within 4 weeks prior to first study treatment. Patients with last radiotherapy >4 weeks prior and no confirmed radiation cystitis may be enrolled.
- Major surgery (TURBT is not considered major surgery) within 4 weeks before first study treatment, or incomplete recovery from postoperative complications.
- Systemic chemotherapy, small-molecule targeted therapy, or investigational therapy within 4 weeks before first study treatment.
- Device-assisted chemotherapy (e.g. TAR-200)
- Residual toxicity ≥ Grade 2 per CTCAE version 6.0 from prior therapy (surgery, intravesical instillation, etc.), except alopecia, pigmentation.
- Bladder or urethral anatomical features that may interfere with HS-10566 implantation, retention, or removal (e.g., urethral stricture, bladder diverticulum, total urinary incontinence, bladder perforation).
- Current or history of clinically significant polyuria (24-hour urine output >4000 mL).
- Requirement for long-term indwelling urinary catheter during study treatment (e.g., urinary obstruction).
- Intermittent catheterization for clinical indications is allowed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100034
Zhisong HE, M.D(Doctor of Medicine), (+86) 13910688432, wyj7074@sohu.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, 210008
Hongqian GUO, M.D(Doctor of Medicine), (+86) 025 83106666, gymwpi@126.com
About this study
Official title: A Phase I/II Clinical Study Evaluating the Safety, Efficacy, Tolerability, and Pharmacokinetics of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy
This is a multicenter, open-label, Phase I/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder cancer who are ineligible for or refuse radical cystectomy. The study comprises two distinct phases: a dose exploration phase and a proof-of-concept phase.
Read the detailed description
The study will commence with a dose exploration phase employing a safety lead-in approach. Treatment cycles are 28 days in duration, with investigational product administration continuing for 2 years or until disease progression or fulfillment of other treatment discontinuation criteria. Each dose level will enroll 6 participants for dose-limiting toxicity (DLT) assessment to evaluate the tolerability, safety, and PK/PD profiles of HS-10566. The Safety Review Committee (SRC) will determine subsequent dose levels for exploration via joint review.
Following identification of safe dose levels in the exploration phase, one dose cohort will advance to the proof-of-concept phase, with each cohort enrolling up to 50 participants to further assess therapeutic efficacy and safety.
- Being tested
- HS-10566
- Keywords
- High-risk Non-muscle-invasive Bladder Neoplasms Administration, Intravesical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10566Drug
HS-10566 is an intravesical gemcitabine delivery system available in two drug-loaded strengths: 0.3 g gemcitabine and 0.6 g gemcitabine.
HS-10566Drug
HS-10566 is an intravesical gemcitabine delivery system available in two drug-loaded strengths: 0.3 g gemcitabine and 0.6 g gemcitabine.
HS-10566Drug
HS-10566 is an intravesical gemcitabine delivery system available in two drug-loaded strengths: 0.3 g gemcitabine and 0.6 g gemcitabine.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1:Bacillus Calmette-Guerin (BCG)-unresponsive participants with carcinoma in situ. | Experimental | HS-10566 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, on Day 1 and will be dosed Q4W for up to the first 24 weeks (6 months), then every 12 weeks through Week 96 (Year 2). Receives: Drug: HS-10566 |
| Arm 2: BCG-unresponsive participants with high-risk papillary-only disease | Experimental | HS-10566 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, on Day 1 and will be dosed Q4W for up to the first 24 weeks (6 months), then every 12 weeks through Week 96 (Year 2). Receives: Drug: HS-10566 |
| Arm 3: BCG-naïve participants with high-risk disease | Experimental | HS-10566 is placed into the bladder through a urinary placement catheter in participants with BCG-naïve high-risk disease, on Day 1 and will be dosed Q4W for up to the first 24 weeks (6 months), then every 12 weeks through Week 96 (Year 2). Receives: Drug: HS-10566 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: RP2D
Measured: Up to 5 months
Phase II Arm 1: overall complete response (CR) rate
Overall CR rate is defined as the percentage of participants achieving a CR at any time post-treatment. It will be measured by determining the percentage of participants without presence of high-grade disease using results from cystoscopy and centrally read urine cytology at any time point.
Measured: Up to 36 months
Phase II Arm 2: disease-free survival (DFS)
DFS will be measured as the time from the date of first dose of study treatment to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first.
Measured: Up to 36 months
Phase II Arm 3: event-free survival (EFS)
EFS will be measured as the time from the date of first dose of study treatment to either the time of the persistence of CIS after 6 months, the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first.
Measured: Up to 36 months
Secondary outcomes (6)
Phase I: Incidence and severity of treatment-emergent adverse events
Incidence of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Measured: Up to 36 months
Concentrations of Gemcitabine and 2',2' difluorodeoxyuridine (dFdU) in Urine and Plasma
Concentrations of gemcitabine and its metabolite dFdU in urine and plasma will be assessed.
Measured: up to 2 months
Phase I and Phase II Arm 3: overall complete response (CR) rate
Overall CR rate is defined as the percentage of participants achieving a CR at any time post-treatment. It will be measured by determining the percentage of participants without presence of high-grade disease using results from cystoscopy and centrally read urine cytology at any time point.
Measured: Up to 36 months
Phase I and Phase II Arm 1 and Arm 3: duration of CR (DoR)
DOR is defined from the date of first CR achieved to the date of first evidence of recurrence or progression or death (whichever is earlier) for participants who achieve a CR.
Measured: Up to 36 months
Phase I: disease-free survival (DFS)
DFS will be measured as the time from the date of first dose of study treatment to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first.
Measured: Up to 36 months
Overall survival (OS)
Overall survival is defined as the duration of time from study entry to death or the date of last contact.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start5 Aug 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Non-muscle-invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468851
- Sponsor's protocol ID
- HS-10566-101
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study Evaluating the Safety, Efficacy, Tolerability, and Pharmacokinetics of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy
- ClinicalTrials.gov ID
- NCT07468851
- Acronym / sponsor ID
- HS-10566-101
- Keywords
- High-risk Non-muscle-invasive Bladder Neoplasms Administration, Intravesical
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 13 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.
This is a multicenter, open-label, Phase I/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder cancer who are ineligible for or refuse radical cystectomy. The study comprises two distinct phases: a dose exploration phase and a proof-of-concept phase.
Detailed description
The study will commence with a dose exploration phase employing a safety lead-in approach. Treatment cycles are 28 days in duration, with investigational product administration continuing for 2 years or until disease progression or fulfillment of other treatment discontinuation criteria. Each dose level will enroll 6 participants for dose-limiting toxicity (DLT) assessment to evaluate the tolerability, safety, and PK/PD profiles of HS-10566. The Safety Review Committee (SRC) will determine subsequent dose levels for exploration via joint review.
Following identification of safe dose levels in the exploration phase, one dose cohort will advance to the proof-of-concept phase, with each cohort enrolling up to 50 participants to further assess therapeutic efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1:Bacillus Calmette-Guerin (BCG)-unresponsive participants with carcinoma in situ. | Experimental | Drug: HS-10566HS-10566 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, on Day 1 and will be dosed Q4W for up to the first 24 weeks (6 months), then every 12 weeks through Week 96 (Year 2). |
| Arm 2: BCG-unresponsive participants with high-risk papillary-only disease | Experimental | Drug: HS-10566HS-10566 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, on Day 1 and will be dosed Q4W for up to the first 24 weeks (6 months), then every 12 weeks through Week 96 (Year 2). |
| Arm 3: BCG-naïve participants with high-risk disease | Experimental | Drug: HS-10566HS-10566 is placed into the bladder through a urinary placement catheter in participants with BCG-naïve high-risk disease, on Day 1 and will be dosed Q4W for up to the first 24 weeks (6 months), then every 12 weeks through Week 96 (Year 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Men or women aged greater than or equal to (≥) 18 years.
- Signed informed consent form.
- Histologically confirmed non-muscle-invasive bladder urothelial carcinoma (i.e., transitional cell carcinoma). Mixed tumor types predominantly consisting of urothelial carcinoma are eligible. Patients diagnosed with neuroendocrine, micropapillary, signet-ring cell, plasmacytoid, or sarcomatoid features are excluded.
- Patients with non-muscle-invasive bladder cancer (NMIBC) who have undergone prior transurethral resection of bladder tumor (TURBT) and who refuse or are ineligible for radical cystectomy, and meet one of the following two populations:
- Participants must have undergone TURBT within 12 weeks prior to signing informed consent and meet the following criteria:
Key exclusion criteria (17 listed)
- Histopathologically confirmed muscle invasive (pathologic T stage ≥ T2), locally advanced, unresectable, or metastatic urothelial carcinoma.
- Urothelial carcinoma outside the bladder (e.g., urethra, ureter, renal pelvis) unless radically resected with no disease recurrence for > 2 years.
- History of other primary solid tumors, except:
- Has received or is receiving any of the following treatments:
- Residual toxicity ≥ Grade 2 per CTCAE version 6.0 from prior therapy (surgery, intravesical instillation, etc.), except alopecia, pigmentation.
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 |
|---|---|---|
| HS-10566HS-10566 is an intravesical gemcitabine delivery system available in two drug-loaded strengths: 0.3 g gemcitabine and 0.6 g gemcitabine. | Drug | Arm 1:Bacillus Calmette-Guerin (BCG)-unresponsive participants with carcinoma in situ. |
| HS-10566HS-10566 is an intravesical gemcitabine delivery system available in two drug-loaded strengths: 0.3 g gemcitabine and 0.6 g gemcitabine. | Drug | Arm 2: BCG-unresponsive participants with high-risk papillary-only disease |
| HS-10566HS-10566 is an intravesical gemcitabine delivery system available in two drug-loaded strengths: 0.3 g gemcitabine and 0.6 g gemcitabine. | Drug | Arm 3: BCG-naïve participants with high-risk disease |
Primary outcome
Phase I: RP2D
Time frame: Up to 5 months
Phase II Arm 1: overall complete response (CR) rate
Time frame: Up to 36 months
Overall CR rate is defined as the percentage of participants achieving a CR at any time post-treatment. It will be measured by determining the percentage of participants without presence of high-grade disease using results from cystoscopy and centrally read urine cytology at any time point.
Phase II Arm 2: disease-free survival (DFS)
Time frame: Up to 36 months
DFS will be measured as the time from the date of first dose of study treatment to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first.
Phase II Arm 3: event-free survival (EFS)
Time frame: Up to 36 months
EFS will be measured as the time from the date of first dose of study treatment to either the time of the persistence of CIS after 6 months, the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first.
6 secondary outcomes
Phase I: Incidence and severity of treatment-emergent adverse events
Time frame: Up to 36 months
Concentrations of Gemcitabine and 2',2' difluorodeoxyuridine (dFdU) in Urine and Plasma
Time frame: up to 2 months
Phase I and Phase II Arm 3: overall complete response (CR) rate
Time frame: Up to 36 months
Phase I and Phase II Arm 1 and Arm 3: duration of CR (DoR)
Time frame: Up to 36 months
Phase I: disease-free survival (DFS)
Time frame: Up to 36 months
Overall survival (OS)
Time frame: Up to 36 months
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 4 Sep 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HS-10566 in people with High-risk Non-muscle-invasive Bladder Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 2 sites in China.
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 17 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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, M.D(Doctor of Medicine) ((+86) 13910688432, wyj7074@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: RP2D (time frame: Up to 5 months). The study lists 4 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 4 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.