UrologyPhase 2NCT07151560
Efficacy and Safety of Two Bladder-preserving Treatment Durations With Disitamab Vedotin Plus Toripalimab Combination in Her2-expressing Muscle-invasive Bladder Cancer: A Phase II, Open-Label, Randomized Clinical Trial
A Phase 2 study testing 6 cycle RC48 and JS001 and 12 cycle RC48 and JS001 in people with Urology, run by Renmin Hospital of Wuhan University.
Trial summary
This study aims to evaluate the efficacy of disitamab vedotin combined with toripalimab as a bladder-preserving treatment combination in patients with HER2 positive locally advanced MIBC, including one year bladder-intact DFS (BI-DFS) and safety. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urology
- What is being tested?
- 6 cycle RC48 and JS001 and 12 cycle RC48 and JS001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2025to 30 Aug 2030
- Phase
- Phase 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary agreement to participate in the study and provision of signed and dated informed consent form.
- Male or female, aged ≥ 18 years.
- Life expectancy of ≥ 18 months.
- Pathologically and radiologically confirmed diagnosis of muscle-invasive bladder cancer (MIBC), clinical stage cT2-4aN0M0.
- Ability to provide tumor tissue specimen from the primary site for HER2 testing; HER2 expression of IHC 1+, 2+, or 3+.
- No prior systemic therapy for bladder cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate cardiac, bone marrow, hepatic, and renal function (as per the reference ranges of the investigating center).
Who cannot join
- History of malignancies other than urothelial carcinoma, with the following exceptions:Patients who have received potentially curative therapy and have no evidence of the disease for 5 years.Adequately treated basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other in situ carcinomas that have undergone curative resection.
- Conditions affecting drug absorption, distribution, metabolism, or excretion.
- Prior allogeneic stem cell or solid organ transplantation.Prior systemic anti-cancer therapy (including Chinese herbal medications with anti-cancer indications).Less than 4 weeks between the completion of prior therapy and the first dose of study treatment, or presence of persistent adverse events from previous treatments that have not recovered to ≤ Grade 1 per CTCAE (excluding alopecia or pigmentation).
- History or current presence of congenital or acquired immunodeficiency diseases.
- Active or documented history of autoimmune or inflammatory disorders.
About this study
Official title: Disitamab Vedotin Plus Toripalimab for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer: A Phase II, Open-Label, Randomized Clinical Trial
This study aims to evaluate the efficacy of disitamab vedotin combined with toripalimab as a bladder-preserving treatment combination in patients with HER2 positive locally advanced MIBC, including one year bladder-intact DFS (BI-DFS) and safety.
Read the detailed description
Eligible pts are aged 18 years with predominant urothelial carcinoma, who were HER2-expressing (IHC1+/2+/3+) and unsuitable for platinum-based chemotherapy; not received systematic treatment in the past and ECOG PS of 0-1. A total of 60 patients are planned to be enrolled. All subjects will undergo initial diagnostic transurethral resection of bladder tumor (TURBT) followed by pharmacotherapy initiation within two weeks postoperatively. In Stage 1, patients will receive four cycles of RC48-ADC (2mg/kg, iv, D1, Q2W) combined with toripalimab (3mg/kg, iv, Q2W). Patients achieving clinical complete response (cCR) will undergo Re-cTURBT with multi-site bladder biopsies to confirm local pathological complete response (pCR). Patients who fail to achieve cCR will undergo radical cystectomy (RC). It should be noted that local pCR here refers to the pathological assessment of residual tumors through Re-cTURBT and multipoint biopsies in patients who achieved complete clinical response (cCR) and requested bladder preservation. Patients attaining local pCR will proceed to the Stage 2 and be randomized into two cohorts: Cohort 1 will receive RC48-ADC (2mg/kg, iv, D1, Q3W) plus toripalimab (3mg/kg, iv, Q3W) for 6 cycles, while Cohort 2 will undergo the same regimen for 6 cycles followed with RC48 (2mg/kg, iv, D1, Q4W) combined with toripalimab (2mg/kg, iv, D1, Q4W) for 6 additional cycles. The primary end point is one year BI-DFS. The secondary end points included overall survival (OS), recurrence-free survival (RFS), clinical complete responsec (cCR) and safety.
- Conditions
- Urology
- Being tested
- 6 cycle RC48 and JS001, 12 cycle RC48 and JS001
- Keywords
- Bladder-preserving, Disitamab Vedotin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 cycle RC48 and JS001Drug
Different medication cycles
12 cycle RC48 and JS001Drug
Different medication cycles
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1 will receive RC48-ADC plus toripalimab for 6 cycles Receives: Drug: 6 cycle RC48 and JS001 |
| Cohort 2 | Experimental | Cohort 2 will receive RC48-ADC and JS001 for 12 cycles Receives: Drug: 12 cycle RC48 and JS001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
one year BI-DFS
One-year bladder-intact disease-free survival (BI-DFS) rate.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrologyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Fan, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151560
- Sponsor's protocol ID
- WDRY2025-K030
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 3 Sep 2025
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disitamab Vedotin Plus Toripalimab for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer: A Phase II, Open-Label, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07151560
- Acronym / sponsor ID
- WDRY2025-K030
- Conditions
- Urology
- Keywords
- Bladder-preserving, Disitamab Vedotin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 3 Sep 2025 (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 aims to evaluate the efficacy of disitamab vedotin combined with toripalimab as a bladder-preserving treatment combination in patients with HER2 positive locally advanced MIBC, including one year bladder-intact DFS (BI-DFS) and safety.
Detailed description
Eligible pts are aged 18 years with predominant urothelial carcinoma, who were HER2-expressing (IHC1+/2+/3+) and unsuitable for platinum-based chemotherapy; not received systematic treatment in the past and ECOG PS of 0-1. A total of 60 patients are planned to be enrolled. All subjects will undergo initial diagnostic transurethral resection of bladder tumor (TURBT) followed by pharmacotherapy initiation within two weeks postoperatively. In Stage 1, patients will receive four cycles of RC48-ADC (2mg/kg, iv, D1, Q2W) combined with toripalimab (3mg/kg, iv, Q2W). Patients achieving clinical complete response (cCR) will undergo Re-cTURBT with multi-site bladder biopsies to confirm local pathological complete response (pCR). Patients who fail to achieve cCR will undergo radical cystectomy (RC). It should be noted that local pCR here refers to the pathological assessment of residual tumors through Re-cTURBT and multipoint biopsies in patients who achieved complete clinical response (cCR) and requested bladder preservation. Patients attaining local pCR will proceed to the Stage 2 and be randomized into two cohorts: Cohort 1 will receive RC48-ADC (2mg/kg, iv, D1, Q3W) plus toripalimab (3mg/kg, iv, Q3W) for 6 cycles, while Cohort 2 will undergo the same regimen for 6 cycles followed with RC48 (2mg/kg, iv, D1, Q4W) combined with toripalimab (2mg/kg, iv, D1, Q4W) for 6 additional cycles. The primary end point is one year BI-DFS. The secondary end points included overall survival (OS), recurrence-free survival (RFS), clinical complete responsec (cCR) and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: 6 cycle RC48 and JS001Cohort 1 will receive RC48-ADC plus toripalimab for 6 cycles |
| Cohort 2 | Experimental | Drug: 12 cycle RC48 and JS001Cohort 2 will receive RC48-ADC and JS001 for 12 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntary agreement to participate in the study and provision of signed and dated informed consent form.
- Male or female, aged ≥ 18 years.
- Life expectancy of ≥ 18 months.
- Pathologically and radiologically confirmed diagnosis of muscle-invasive bladder cancer (MIBC), clinical stage cT2-4aN0M0.
- Ability to provide tumor tissue specimen from the primary site for HER2 testing; HER2 expression of IHC 1+, 2+, or 3+.
Key exclusion criteria (5 listed)
- History of malignancies other than urothelial carcinoma, with the following exceptions:Patients who have received potentially curative therapy and have no evidence of the disease for 5 years.Adequately treated basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other in situ carcinomas that have undergone curative resection.
- Conditions affecting drug absorption, distribution, metabolism, or excretion.
- Prior allogeneic stem cell or solid organ transplantation.Prior systemic anti-cancer therapy (including Chinese herbal medications with anti-cancer indications).Less than 4 weeks between the completion of prior therapy and the first dose of study treatment, or presence of persistent adverse events from previous treatments that have not recovered to ≤ Grade 1 per CTCAE (excluding alopecia or pigmentation).
- History or current presence of congenital or acquired immunodeficiency diseases.
- Active or documented history of autoimmune or inflammatory disorders.
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 |
|---|---|---|
| 6 cycle RC48 and JS001Different medication cycles | Drug | Cohort 1 |
| 12 cycle RC48 and JS001Different medication cycles | Drug | Cohort 2 |
Primary outcome
one year BI-DFS
Time frame: one year
One-year bladder-intact disease-free survival (BI-DFS) rate.
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 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 6 cycle RC48 and JS001 and 12 cycle RC48 and JS001 in people with Urology, run by Renmin Hospital of Wuhan University.
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 8 inclusion and 5 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 Sep 2025. 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 phase mean?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one year BI-DFS (time frame: one year). 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 Sep 2025.