Bladder CancerPhase 1NCT07783815
A Study to Evaluate the Efficacy and Safety of Intravesical Instillation of Disitamab Vedotin Combined With Toripalimab in Patients With HER2-Positive High-Risk Non-Muscle Invasive Bladder Cancer Who Are BCG-Naïve or Have BCG Failure
A Phase 1 study testing Intravesical Instillation of Disitamab Vedotin Combined with Toripalimab in people with Bladder Cancer, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This study is an open-label, single-arm investigator-initiated clinical trial, aiming to evaluate the efficacy and safety of vicedetinib bladder instillation combined with teprotumumab in the treatment of patients with HER2-expressing, previously untreated, or BCG-resistant high-risk non-muscle-invasive bladder cancer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Intravesical Instillation of Disitamab Vedotin Combined with Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Feb 2030
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily agree to participate in the research and sign the informed consent form.
- Within 3 weeks after TURBT surgery, the tumor tissue specimens obtained from the subjects were subjected to immunohistochemical (IHC) testing for HER2 expression, which met the criteria of 1+, 2+ or 3+. If the IHC result was 2+, FISH verification for amplification was required.
- ECOG physical condition: 0 - 2 points.
- Sufficient heart, bone marrow, liver and kidney functions should meet the following standards within 7 days before the drug administration study (normal values are based on the clinical trial center): Left ventricular ejection fraction ≥ 50%; Hemoglobin ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); ALT and AST ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance rate (CrCl) ≥ 50 mL/min according to the Cockcroft-Gault formula.
- Within 3 weeks after TURBT surgery, the tumor tissue specimens obtained from the subjects were subjected to immunohistochemical (IHC) testing for HER2 expression, which met the criteria of 1+, 2+ or 3+. If the IHC result was 2+, FISH verification for amplification was required.
- ECOG physical condition: 0 - 2 points.
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- Sufficient heart, bone marrow, liver and kidney functions should meet the following standards within 7 days before the drug administration study (normal values are based on the clinical trial center): Left ventricular ejection fraction ≥ 50%; Hemoglobin ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); ALT and AST ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance rate (CrCl) ≥ 50 mL/min according to the Cockcroft-Gault formula.
- The female subjects should be patients who have undergone surgical sterilization or menopause, or those who agree to use at least one medically approved contraceptive method (such as intrauterine device, contraceptive pills or condoms) during the study treatment period and within 6 months after the end of the study treatment. The blood pregnancy test must be negative within 7 days before the subject is enrolled in the study. False positive results can be excluded after confirming pregnancy by the investigator and then the subject can be enrolled. Male subjects should agree to use at least one medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment.
- Willing and able to comply with the arrangements of the trial and follow-up procedures.
- Willing and able to comply with the arrangements of the trial and follow-up procedures.
Who cannot join
- Muscle-invasive bladder cancer (T2 and above) and/or those with regional lymph node and distant metastasis.
- Combined urinary tract urothelial carcinoma outside the bladder (i.e., in the urethra, ureters or renal pelvis).
- The study excluded any patients who had received any other anti-tumor treatments within 4 weeks prior to the administration of the drug, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. This exclusion did not include the one-time perfusion chemotherapy immediately performed after TURBT.
- Before the start of the drug study, there was no recovery from the adverse events caused by the previously used anti-tumor drugs to the 0-1 level of CECAT within 2 weeks.
- Those who started the drug administration within 4 weeks before the study or those who planned to undergo major surgery during the trial period.
- Serological virological examination (based on the normal values of the research center): HBsAg or HBcAb test results are positive, and HBVDNA copy number is also positive; HCVAb test result is positive, and HCV RNA test result is also positive; HIVAb test result is positive.
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- The study excluded participants who had received live vaccines within 4 weeks prior to the start of the treatment or who planned to receive any vaccines during the study period (except for the novel coronavirus inactivated virus vaccine).
- Heart failure classified as grade 3 or above by the New York Heart Association (NYHA) in the United States.
- The study excluded cases where there had been severe arterial/venous thrombosis events or cardiovascular/cerebrovascular accidents within 6 months before administration, such as deep vein thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc. However, cases of asymptomatic and non-requirement-of-clinical-intervention lacunar cerebral infarction were included.
- There are active or progressive infections that require systematic treatment, such as active tuberculosis.
- There are systemic diseases that have been judged by the researchers to be active and not yet under stable control, as well as severe comorbidities, including diabetes, hypertension, liver cirrhosis, interstitial pneumonia, obstructive pulmonary disease, etc.
- Previous history of receiving allogeneic hematopoietic stem cell transplantation or organ transplantation.
- Those who are known to be allergic to RC48-ADC/Teripipor or any of its components or any of the excipients.
- Pregnant or lactating women.
- It is estimated that the patient's compliance with this clinical study is insufficient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xiangya Hospital
Changsha, Hunan
Huihuang Li, Doctor of Medicine, +86-731-8975-3011, lhhuang1994@163.com
About this study
Official title: An Open-Label, Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Intravesical Instillation of Disitamab Vedotin Combined With Toripalimab in Patients With HER2-Positive High-Risk Non-Muscle Invasive Bladder Cancer Who Are BCG-Naïve or Have BCG Failure
This study is an open-label, single-arm investigator-initiated clinical trial, aiming to evaluate the efficacy and safety of vicedetinib bladder instillation combined with teprotumumab in the treatment of patients with HER2-expressing, previously untreated, or BCG-resistant high-risk non-muscle-invasive bladder cancer (NMIBC). The subjects to be included in the study must have undergone standard TURBT within 3 weeks before enrollment, removed all visible lesions, and had a clear pathological diagnosis of NMIBC, with their risk classification according to the "Chinese Bladder Cancer Diagnosis and Treatment Guidelines (2022)" falling into the high-risk group (including extremely high-risk group). All surgical tumor specimens of the included subjects underwent HER2 testing, indicating HER2 expression, defined as immunohistochemistry (IHC) 1+, 2+ or 3+, with FISH verification for amplification if IHC 2+ is present. The subjects were divided into two groups based on whether they had received BCG treatment in the past: one group was high-risk NMIBC patients who had not received BCG treatment, including one of the following situations: ① refused BCG treatment, ② had contraindications to BCG use, ③ BCG was inaccessible; the other group was high-risk NMIBC patients who had no response to BCG, meeting any of the following criteria: ① had persistent/recurrent high-risk NMIBC within 12 months (±1 month) after adequate BCG treatment, ② had high-grade T1 disease during the first assessment after induction BCG treatment. Adequate BCG treatment was defined as completing at least 5 BCG bladder instillations within 2 months, and then at least 2 BCG bladder instillations for 6 consecutive weeks within the next 10 months, meaning at least "5+2" BCG bladder instillations within approximately 12 months. Eligible subjects received vicedetinib bladder instillation combined with teprotumumab treatment; vicedetinib was administered once weekly at 180mg for 8 times. For patients receiving treatment, if there was no occurrence of persistent/recurrent NMIBC, disease progression, or intolerable toxicity, they would receive maintenance bladder instillation with vicedetinib for one year, with the maintenance regimen being: once every 4 weeks for 10 times. Teprotumumab: 240mg per dose, intravenous, once every 3 weeks for 1 year. Patients were required to collect urine samples before the first treatment and after the last treatment. Safety during the study was evaluated according to the NCI-CTCAE V5.0 standard, and the observation indicators included vital signs, physical examination, laboratory tests, electrocardiogram and echocardiogram examinations, adverse events and serious adverse events.
- Conditions
- Bladder Cancer
- Being tested
- Intravesical Instillation of Disitamab Vedotin Combined with Toripalimab
- Keywords
- High-risk non-muscle-invasive bladder cancer, Disitamab Vedotin, Toripalimab, Bladder instillation, HER2
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical Instillation of Disitamab Vedotin Combined with ToripalimabDrug
Eligible subjects will be enrolled and treated with intravesical instillation of disitamab vedotin combined with toripalimab.
Disitamab vedotin will be administered at a dose of 180 mg once weekly for 8 consecutive cycles.
For treated patients without persistent/recurrent NMIBC, disease progression, or intolerable toxicity, maintenance intravesical instillation of disitamab vedotin will be performed within 1 year. The regimen for maintenance therapy is 180 mg once every 4 weeks for 10 consecutive cycles.
Toripalimab will be administered intravenously at a dose of 240 mg once every 3 weeks for 1 consecutive year.
| Study group | Role | What they receive |
|---|---|---|
| Intravesical Instillation of Disitamab Vedotin Combined with Toripalimab | Experimental | Eligible subjects will be enrolled and treated with intravesical instillation of disitamab vedotin combined with toripalimab.
Disitamab vedotin will be administered at a dose of 180 mg once weekly for 8 consecutive cycles.
For treated patients without persistent/recurrent NMIBC, disease progression, or intolerable toxicity, maintenance intravesical instillation of disitamab vedotin will be performed within 1 year. The regimen for maintenance therapy is 180 mg once every 4 weeks for 10 consecutive cycles.
Toripalimab will be administered intravenously at a dose of 240 mg once every 3 weeks for 1 consecutive year. Receives: Drug: Intravesical Instillation of Disitamab Vedotin Combined with Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The one-year recurrence-free survival rate of patients with high-risk NMIBC
After all subjects have been enrolled and followed up for an additional 12 months, or upon achievement of the required number of positive events, Recurrence-Free Survival (RFS) will be analyzed using the Kaplan-Meier method.
The median recurrence-free time will be estimated via the Kaplan-Meier method. Hazard ratios (HR) and their 95% confidence intervals will be calculated using the Cox proportional hazards model.
Measured: One year after the treatment
Secondary outcomes (4)
The clinical complete remission rates for 3 months and 6 months
the proportion of patients achieving clinical complete remission at 3 months and 6 months.
Measured: Three months and six months after the treatment
Overall survival period
Overall Survival (OS) is defined as the time from the date of initial treatment to death from any cause. Patients who remain alive at the last follow-up will be censored.
Measured: through study completion, an average of 3 years
Progression-free survival time
Progression-free survival (PFS) is defined as the time from the initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever comes first.
Measured: through study completion, an average of 3 years
Adverse event
An adverse event (AE) is any unfavorable or unintended medical occurrence in a subject administered a study drug, which does not necessarily have a causal relationship with the study treatment.
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783815
- Sponsor's protocol ID
- Xiangya202604051
- Status last verified
- Aug 2026
- First submitted
- 20 Apr 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Intravesical Instillation of Disitamab Vedotin Combined With Toripalimab in Patients With HER2-Positive High-Risk Non-Muscle Invasive Bladder Cancer Who Are BCG-Naïve or Have BCG Failure
- ClinicalTrials.gov ID
- NCT07783815
- Acronym / sponsor ID
- Xiangya202604051
- Conditions
- Bladder Cancer
- Keywords
- High-risk non-muscle-invasive bladder cancer, Disitamab Vedotin, Toripalimab, Bladder instillation, HER2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 25 Aug 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 study is an open-label, single-arm investigator-initiated clinical trial, aiming to evaluate the efficacy and safety of vicedetinib bladder instillation combined with teprotumumab in the treatment of patients with HER2-expressing, previously untreated, or BCG-resistant high-risk non-muscle-invasive bladder cancer (NMIBC). The subjects to be included in the study must have undergone standard TURBT within 3 weeks before enrollment, removed all visible lesions, and had a clear pathological diagnosis of NMIBC, with their risk classification according to the "Chinese Bladder Cancer Diagnosis and Treatment Guidelines (2022)" falling into the high-risk group (including extremely high-risk group). All surgical tumor specimens of the included subjects underwent HER2 testing, indicating HER2 expression, defined as immunohistochemistry (IHC) 1+, 2+ or 3+, with FISH verification for amplification if IHC 2+ is present. The subjects were divided into two groups based on whether they had received BCG treatment in the past: one group was high-risk NMIBC patients who had not received BCG treatment, including one of the following situations: ① refused BCG treatment, ② had contraindications to BCG use, ③ BCG was inaccessible; the other group was high-risk NMIBC patients who had no response to BCG, meeting any of the following criteria: ① had persistent/recurrent high-risk NMIBC within 12 months (±1 month) after adequate BCG treatment, ② had high-grade T1 disease during the first assessment after induction BCG treatment. Adequate BCG treatment was defined as completing at least 5 BCG bladder instillations within 2 months, and then at least 2 BCG bladder instillations for 6 consecutive weeks within the next 10 months, meaning at least "5+2" BCG bladder instillations within approximately 12 months. Eligible subjects received vicedetinib bladder instillation combined with teprotumumab treatment; vicedetinib was administered once weekly at 180mg for 8 times. For patients receiving treatment, if there was no occurrence of persistent/recurrent NMIBC, disease progression, or intolerable toxicity, they would receive maintenance bladder instillation with vicedetinib for one year, with the maintenance regimen being: once every 4 weeks for 10 times. Teprotumumab: 240mg per dose, intravenous, once every 3 weeks for 1 year. Patients were required to collect urine samples before the first treatment and after the last treatment. Safety during the study was evaluated according to the NCI-CTCAE V5.0 standard, and the observation indicators included vital signs, physical examination, laboratory tests, electrocardiogram and echocardiogram examinations, adverse events and serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravesical Instillation of Disitamab Vedotin Combined with Toripalimab | Experimental | Drug: Intravesical Instillation of Disitamab Vedotin Combined with ToripalimabEligible subjects will be enrolled and treated with intravesical instillation of disitamab vedotin combined with toripalimab. Disitamab vedotin will be administered at a dose of 180 mg once weekly for 8 consecutive cycles. For treated patients without persistent/recurrent NMIBC, disease progression, or intolerable toxicity, maintenance intravesical instillation of disitamab vedotin will be performed within 1 year. The regimen for maintenance therapy is 180 mg once every 4 weeks for 10 consecutive cycles. Toripalimab will be administered intravenously at a dose of 240 mg once every 3 weeks for 1 consecutive year. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily agree to participate in the research and sign the informed consent form.
- Within 3 weeks after TURBT surgery, the tumor tissue specimens obtained from the subjects were subjected to immunohistochemical (IHC) testing for HER2 expression, which met the criteria of 1+, 2+ or 3+. If the IHC result was 2+, FISH verification for amplification was required.
- ECOG physical condition: 0 - 2 points.
- Sufficient heart, bone marrow, liver and kidney functions should meet the following standards within 7 days before the drug administration study (normal values are based on the clinical trial center): Left ventricular ejection fraction ≥ 50%; Hemoglobin ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); ALT and AST ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance rate (CrCl) ≥ 50 mL/min according to the Cockcroft-Gault formula.
- Within 3 weeks after TURBT surgery, the tumor tissue specimens obtained from the subjects were subjected to immunohistochemical (IHC) testing for HER2 expression, which met the criteria of 1+, 2+ or 3+. If the IHC result was 2+, FISH verification for amplification was required.
Key exclusion criteria (15 listed)
- Muscle-invasive bladder cancer (T2 and above) and/or those with regional lymph node and distant metastasis.
- Combined urinary tract urothelial carcinoma outside the bladder (i.e., in the urethra, ureters or renal pelvis).
- The study excluded any patients who had received any other anti-tumor treatments within 4 weeks prior to the administration of the drug, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. This exclusion did not include the one-time perfusion chemotherapy immediately performed after TURBT.
- Before the start of the drug study, there was no recovery from the adverse events caused by the previously used anti-tumor drugs to the 0-1 level of CECAT within 2 weeks.
- Those who started the drug administration within 4 weeks before the study or those who planned to undergo major surgery during the trial period.
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 |
|---|---|---|
| Intravesical Instillation of Disitamab Vedotin Combined with ToripalimabEligible subjects will be enrolled and treated with intravesical instillation of disitamab vedotin combined with toripalimab. Disitamab vedotin will be administered at a dose of 180 mg once weekly for 8 consecutive cycles. For treated patients without persistent/recurrent NMIBC, disease progression, or intolerable toxicity, maintenance intravesical instillation of disitamab vedotin will be performed within 1 year. The regimen for maintenance therapy is 180 mg once every 4 weeks for 10 consecutive cycles. Toripalimab will be administered intravenously at a dose of 240 mg once every 3 weeks for 1 consecutive year. | Drug | Intravesical Instillation of Disitamab Vedotin Combined with Toripalimab |
Primary outcome
The one-year recurrence-free survival rate of patients with high-risk NMIBC
Time frame: One year after the treatment
After all subjects have been enrolled and followed up for an additional 12 months, or upon achievement of the required number of positive events, Recurrence-Free Survival (RFS) will be analyzed using the Kaplan-Meier method. The median recurrence-free time will be estimated via the Kaplan-Meier method. Hazard ratios (HR) and their 95% confidence intervals will be calculated using the Cox proportional hazards model.
4 secondary outcomes
The clinical complete remission rates for 3 months and 6 months
Time frame: Three months and six months after the treatment
Overall survival period
Time frame: through study completion, an average of 3 years
Progression-free survival time
Time frame: through study completion, an average of 3 years
Adverse event
Time frame: through study completion, an average of 3 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 25 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravesical Instillation of Disitamab Vedotin Combined with Toripalimab in people with Bladder Cancer, run by Xiangya Hospital of Central South University at 1 site 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 10 inclusion and 15 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 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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 Huihuang Li, Doctor of Medicine (+86-731-8975-3011, lhhuang1994@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The one-year recurrence-free survival rate of patients with high-risk NMIBC (time frame: One year after the treatment). 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 25 Aug 2026.