Bladder CancerPhase 1NCT07853053
DV Plus Toripalimab With Cetirizine and Mecobalamin Pretreatment in Patients With Locally Advanced Unresectable or Metastatic Bladder Cancer
A Phase 1 study testing Disitamab Vedotin, Toripalimab and Cetirizine in people with Bladder Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This is a prospective, open-label, single-arm exploratory clinical study evaluating the efficacy and safety of disitamab vedotin (RC48) plus toripalimab with cetirizine and mecobalamin in patients with locally advanced unresectable or metastatic bladder cancer who have not received prior systemic therapy for advanced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Disitamab Vedotin, Toripalimab and Cetirizine
- Type of treatment
- Pill or oral medicine, 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 Jan 2027to 31 Dec 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily agrees to participate in the study, is able to provide written informed consent, and is able to understand and comply with the study requirements and assessment schedule.
- Age ≥18 years, regardless of sex.
- Histologically or cytologically confirmed bladder urothelial carcinoma, including pure urothelial carcinoma or mixed bladder carcinoma with a predominant urothelial carcinoma component (≥50%), with clinically diagnosed unresectable locally advanced, recurrent, or metastatic disease that is not suitable for curative surgery or definitive radiotherapy.
- HER2 expression ≥1+ by immunohistochemistry, as determined at the local laboratory using a pretreatment tumor specimen.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function, as demonstrated by the following laboratory values obtained within 14 days before enrollment:
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- The following hematologic criteria must be met without growth factor support within 14 days before sample collection: i. Absolute neutrophil count ≥1.5 × 10^9/L; ii. Platelet count ≥90 × 10^9/L; iii. Hemoglobin ≥90 g/L. b. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 × the upper limit of normal (ULN).
- Total serum bilirubin ≤1.5 × ULN; for participants with Gilbert syndrome or predominantly indirect hyperbilirubinemia of extrahepatic origin, total bilirubin must be ≤3 × ULN.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤2.5 × ULN.
- At least one measurable lesion according to RECIST version 1.1.
- Any adverse events related to prior anticancer treatment must have recovered to Grade 0 or 1 before enrollment, except for clinically insignificant toxicities such as alopecia, pigmentation changes, or stable endocrine abnormalities controlled with replacement therapy.
- No peripheral neuropathy at enrollment. Participants with a history of peripheral neuropathy must have Grade 0 peripheral neuropathy at enrollment.
- Female participants of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during study treatment and for the protocol-specified period after the last dose. Male participants with partners of childbearing potential must also agree to use effective contraception.
Who cannot join
- Prior systemic anticancer treatment for advanced, recurrent, or metastatic bladder cancer, including chemotherapy, immunotherapy, targeted therapy, antibody-drug conjugates (ADCs), or other investigational anticancer agents.
- Prior treatment with disitamab vedotin, another HER2-targeted ADC, or an MMAE-containing ADC; or a history of severe immune-related adverse events associated with prior treatment with PD-1, PD-L1, CTLA-4, or other immune checkpoint inhibitors.
- Known hypersensitivity to disitamab vedotin, toripalimab, cetirizine, mecobalamin, or any component of these agents.
- Grade 2 or higher peripheral neuropathy, or a severe neurologic disorder that, in the investigator's judgment, may interfere with assessment of neurotoxicity, including but not limited to severe diabetic peripheral neuropathy, spinal cord compression, severe spinal canal stenosis, active neuritis, or demyelinating disease.
- Active or previously diagnosed autoimmune disease that may worsen with PD-1 inhibitor therapy, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, systemic sclerosis, vasculitis, autoimmune hepatitis, or multiple sclerosis.
- Receipt of a live vaccine within 28 days before enrollment. Seasonal injectable influenza vaccines that are inactivated are permitted; intranasal live vaccines are not permitted.
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- Active central nervous system metastases, leptomeningeal metastases, or carcinomatous meningitis. Participants with previously treated brain metastases may be considered eligible if the lesions are stable, the participant is asymptomatic, corticosteroids have been discontinued or reduced to a low dose, and enrollment is considered safe by the investigator.
- Requirement for long-term high-dose corticosteroid therapy or other immunosuppressive therapy that, in the investigator's judgment, may interfere with study treatment.
- Clinically significant abnormalities of potassium, sodium, or calcium; hypoalbuminemia; interstitial lung disease; noninfectious pneumonitis; or other uncontrolled systemic diseases that, in the investigator's judgment, may interfere with study treatment, including uncontrolled diabetes mellitus, hypertension, or cardiovascular disease. This includes active cardiac disease within 6 months before enrollment, such as severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, or ventricular arrhythmias requiring medical treatment.
- Untreated chronic hepatitis B infection or hepatitis B virus (HBV) carrier status with HBV DNA ≥500 IU/mL (2500 copies/mL). Participants who are inactive hepatitis B surface antigen carriers or who have stable active HBV infection after continuous antiviral therapy with HBV DNA <500 IU/mL may be enrolled. HBV DNA testing is required only for participants who are positive for hepatitis B core antibody.
- Active hepatitis C infection. Participants with a negative hepatitis C virus (HCV) antibody test during screening, or those with a positive HCV antibody test but negative HCV RNA, may be enrolled. Participants with a positive HCV antibody test must undergo HCV RNA testing.
- History of immunodeficiency, including positive human immunodeficiency virus (HIV) testing or other acquired or congenital immunodeficiency disorders, or a history of allogeneic stem cell transplantation or organ transplantation.
- Major surgery, definitive radiotherapy, or extensive palliative radiotherapy within 4 weeks before enrollment, or unresolved surgery- or radiotherapy-related toxicity above Grade 1.
- Another malignancy within the previous 5 years, except for malignancies that have been definitively treated and are considered to have a low risk of recurrence, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, low-risk prostate cancer, or adequately treated non-muscle-invasive bladder cancer.
- Pregnant or breastfeeding women.
- Drug or alcohol abuse, severe psychiatric illness, cognitive impairment, or any other condition that may interfere with the ability to provide informed consent, comply with study treatment, or complete follow-up.
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
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Wenlong Zhong, PhD, 18510904167, zhongwlong3@mail.sysu.edu.cn
About this study
Official title: Efficacy and Safety of Disitamab Vedotin Plus Toripalimab With Cetirizine and Mecobalamin Pretreatment in Patients With Locally Advanced Unresectable or Metastatic Bladder Cancer: A Single-Arm Clinical Study
This is a prospective, open-label, single-arm exploratory clinical study evaluating the efficacy and safety of disitamab vedotin (RC48) plus toripalimab with cetirizine and mecobalamin in patients with locally advanced unresectable or metastatic bladder cancer who have not received prior systemic therapy for advanced disease.
Disitamab vedotin is a HER2-targeted antibody-drug conjugate, and toripalimab is a PD-1 immune checkpoint inhibitor. Although antibody-drug conjugates have shown antitumor activity in urothelial cancer, treatment-related peripheral neuropathy may affect patients' quality of life and the ability to continue treatment. In this study, cetirizine and mecobalamin are incorporated as a supportive and preventive strategy to explore whether they may help reduce or delay treatment-related peripheral neuropathy while maintaining antitumor activity.
Approximately 10 to 20 participants will be enrolled. The primary outcomes are objective response rate according to RECIST v1.1 and the incidence of treatment-related Grade 2 or higher peripheral neuropathy. Secondary outcomes include overall safety, disease control rate, progression-free survival, and overall survival. Exploratory analyses will evaluate changes in the tumor immune microenvironment, including CD8-positive T-cell infiltration and activation, and their associations with treatment response and peripheral neuropathy.
- Conditions
- Bladder Cancer
- Being tested
- Disitamab Vedotin, Toripalimab, Cetirizine, Mecobalamin
- Keywords
- Disitamab Vedotin, Toripalimab, Cetirizine, Mecobalamin, ADC-related Peripheral Neuropathy
- 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.
Disitamab VedotinDrug
Disitamab vedotin will be administered intravenously at 2.0 mg/kg every 2 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of a new anticancer therapy, or investigator decision to discontinue treatment.
ToripalimabDrug
Toripalimab will be administered intravenously at 240 mg every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of a new anticancer therapy, completion of protocol-specified treatment, or investigator decision to discontinue treatment.
CetirizineDrug
Cetirizine will be administered orally at 10 mg once daily during study treatment as a prophylactic/supportive intervention to explore its potential effects on treatment-related peripheral neuropathy and antitumor immune responses. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of a new anticancer therapy, or investigator decision to discontinue treatment.
MecobalaminDrug
Mecobalamin will be administered orally at 0.5 mg three times daily during study treatment as a prophylactic/supportive intervention to explore its potential effects on treatment-related peripheral neuropathy. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of a new anticancer therapy, or investigator decision to discontinue treatment.
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin Plus Toripalimab With Cetirizine and Mecobalamin | Experimental | Participants will receive disitamab vedotin 2.0 mg/kg intravenously every 2 weeks and toripalimab 240 mg intravenously every 3 weeks, together with cetirizine 10 mg orally once daily and mecobalamin 0.5 mg orally three times daily. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of a new anticancer therapy, completion of protocol-specified treatment where applicable, or investigator decision. Cetirizine and mecobalamin are administered as a prophylactic/supportive strategy to explore their potential effects on treatment-related peripheral neuropathy and antitumor immune responses. Receives: Drug: Disitamab Vedotin; Drug: Toripalimab; Drug: Cetirizine; Drug: Mecobalamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of efficacy-evaluable participants whose best overall response is complete response (CR) or partial response (PR), as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR is calculated as the number of participants with CR or PR divided by the total number of efficacy-evaluable participants.
Measured: From baseline until disease progression, death, initiation of new anticancer therapy, withdrawal of consent, loss to follow-up, or study completion; assessed every 4 weeks (±7 days).
Incidence of Treatment-Related Grade 2 or Higher Peripheral Neuropathy
The proportion of participants in the safety analysis population who develop treatment-related Grade 2 or higher peripheral neuropathy during study treatment. Peripheral neuropathy will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 and may include peripheral sensory neuropathy, peripheral motor neuropathy, paresthesia, numbness, tingling, pain, burning sensation, hypoesthesia, muscle weakness, impaired fine motor function, or gait instability. Events will be considered treatment-related based on investigator assessment.
Measured: From the first dose of study treatment through the end of study treatment.
Secondary outcomes (4)
Incidence of Adverse Events and Serious Adverse Events
Safety will be assessed by the incidence and severity of adverse events (AEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), adverse drug reactions (ADRs), and immune-related adverse events (irAEs). Adverse events will be graded according to NCI-CTCAE version 5.0. Safety assessments will also include laboratory tests, vital signs, and other clinically relevant safety parameters.
Measured: From the first dose through the protocol-defined safety follow-up period; routine safety assessments through 28 days after the last dose, with SAE monitoring through 90 days after the last dose.
Disease Control Rate (DCR)
The proportion of efficacy-evaluable participants whose best overall response is complete response (CR), partial response (PR), or stable disease (SD), as assessed according to RECIST version 1.1. DCR is calculated as (CR + PR + SD) divided by the total number of efficacy-evaluable participants.
Measured: From baseline until disease progression, death, initiation of new anticancer therapy, withdrawal of consent, loss to follow-up, or study completion; assessed every 4 weeks (±7 days).
Progression-Free Survival (PFS)
PFS is defined as the time from the first administration of study treatment to the first documented radiographic disease progression or death from any cause, whichever occurs first. Participants without progression or death at the time of analysis will be censored at the date of their last evaluable tumor assessment.
Measured: From the first administration of study treatment until documented disease progression or death from any cause, whichever occurs first, through study completion.
Overall Survival (OS)
OS is defined as the time from the first administration of study treatment to death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive.
Measured: From the first administration of study treatment until death from any cause, through study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (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 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Model description
- This is a prospective, open-label, single-arm, exploratory interventional study using a Bayesian adaptive design. All enrolled participants will receive disitamab vedotin plus toripalimab with cetirizine and mecobalamin. The study plans to enroll 10 to 20 participants. Interim analyses will be conducted after 10, 12, 14, 16, and 18 evaluable participants, with a maximum sample size of 20, to dynamically assess both antitumor efficacy and treatment-related peripheral neuropathy.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853053
- Sponsor's protocol ID
- SYSKY-2026-733-01
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Disitamab Vedotin Plus Toripalimab With Cetirizine and Mecobalamin Pretreatment in Patients With Locally Advanced Unresectable or Metastatic Bladder Cancer: A Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07853053
- Acronym / sponsor ID
- SYSKY-2026-733-01
- Conditions
- Bladder Cancer
- Keywords
- Disitamab Vedotin, Toripalimab, Cetirizine, Mecobalamin, ADC-related Peripheral Neuropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 Oct 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 prospective, open-label, single-arm exploratory clinical study evaluating the efficacy and safety of disitamab vedotin (RC48) plus toripalimab with cetirizine and mecobalamin in patients with locally advanced unresectable or metastatic bladder cancer who have not received prior systemic therapy for advanced disease.
Disitamab vedotin is a HER2-targeted antibody-drug conjugate, and toripalimab is a PD-1 immune checkpoint inhibitor. Although antibody-drug conjugates have shown antitumor activity in urothelial cancer, treatment-related peripheral neuropathy may affect patients' quality of life and the ability to continue treatment. In this study, cetirizine and mecobalamin are incorporated as a supportive and preventive strategy to explore whether they may help reduce or delay treatment-related peripheral neuropathy while maintaining antitumor activity.
Approximately 10 to 20 participants will be enrolled. The primary outcomes are objective response rate according to RECIST v1.1 and the incidence of treatment-related Grade 2 or higher peripheral neuropathy. Secondary outcomes include overall safety, disease control rate, progression-free survival, and overall survival. Exploratory analyses will evaluate changes in the tumor immune microenvironment, including CD8-positive T-cell infiltration and activation, and their associations with treatment response and peripheral neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, open-label, single-arm, exploratory interventional study using a Bayesian adaptive design. All enrolled participants will receive disitamab vedotin plus toripalimab with cetirizine and mecobalamin. The study plans to enroll 10 to 20 participants. Interim analyses will be conducted after 10, 12, 14, 16, and 18 evaluable participants, with a maximum sample size of 20, to dynamically assess both antitumor efficacy and treatment-related peripheral neuropathy.
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin Plus Toripalimab With Cetirizine and Mecobalamin | Experimental | Drug: Disitamab Vedotin, Drug: Toripalimab, Drug: Cetirizine, Drug: MecobalaminParticipants will receive disitamab vedotin 2.0 mg/kg intravenously every 2 weeks and toripalimab 240 mg intravenously every 3 weeks, together with cetirizine 10 mg orally once daily and mecobalamin 0.5 mg orally three times daily. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of a new anticancer therapy, completion of protocol-specified treatment where applicable, or investigator decision. Cetirizine and mecobalamin are administered as a prophylactic/supportive strategy to explore their potential effects on treatment-related peripheral neuropathy and antitumor immune responses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntarily agrees to participate in the study, is able to provide written informed consent, and is able to understand and comply with the study requirements and assessment schedule.
- Age ≥18 years, regardless of sex.
- Histologically or cytologically confirmed bladder urothelial carcinoma, including pure urothelial carcinoma or mixed bladder carcinoma with a predominant urothelial carcinoma component (≥50%), with clinically diagnosed unresectable locally advanced, recurrent, or metastatic disease that is not suitable for curative surgery or definitive radiotherapy.
- HER2 expression ≥1+ by immunohistochemistry, as determined at the local laboratory using a pretreatment tumor specimen.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (16 listed)
- Prior systemic anticancer treatment for advanced, recurrent, or metastatic bladder cancer, including chemotherapy, immunotherapy, targeted therapy, antibody-drug conjugates (ADCs), or other investigational anticancer agents.
- Prior treatment with disitamab vedotin, another HER2-targeted ADC, or an MMAE-containing ADC; or a history of severe immune-related adverse events associated with prior treatment with PD-1, PD-L1, CTLA-4, or other immune checkpoint inhibitors.
- Known hypersensitivity to disitamab vedotin, toripalimab, cetirizine, mecobalamin, or any component of these agents.
- Grade 2 or higher peripheral neuropathy, or a severe neurologic disorder that, in the investigator's judgment, may interfere with assessment of neurotoxicity, including but not limited to severe diabetic peripheral neuropathy, spinal cord compression, severe spinal canal stenosis, active neuritis, or demyelinating disease.
- Active or previously diagnosed autoimmune disease that may worsen with PD-1 inhibitor therapy, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, systemic sclerosis, vasculitis, autoimmune hepatitis, or multiple sclerosis.
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 |
|---|---|---|
| Disitamab VedotinDisitamab vedotin will be administered intravenously at 2.0 mg/kg every 2 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of a new anticancer therapy, or investigator decision to discontinue treatment. | Drug | Disitamab Vedotin Plus Toripalimab With Cetirizine and Mecobalamin |
| ToripalimabToripalimab will be administered intravenously at 240 mg every 3 weeks. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of a new anticancer therapy, completion of protocol-specified treatment, or investigator decision to discontinue treatment. | Drug | Disitamab Vedotin Plus Toripalimab With Cetirizine and Mecobalamin |
| CetirizineCetirizine will be administered orally at 10 mg once daily during study treatment as a prophylactic/supportive intervention to explore its potential effects on treatment-related peripheral neuropathy and antitumor immune responses. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of a new anticancer therapy, or investigator decision to discontinue treatment. | Drug | Disitamab Vedotin Plus Toripalimab With Cetirizine and Mecobalamin |
| MecobalaminMecobalamin will be administered orally at 0.5 mg three times daily during study treatment as a prophylactic/supportive intervention to explore its potential effects on treatment-related peripheral neuropathy. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of a new anticancer therapy, or investigator decision to discontinue treatment. | Drug | Disitamab Vedotin Plus Toripalimab With Cetirizine and Mecobalamin |
Primary outcome
Objective Response Rate (ORR)
Time frame: From baseline until disease progression, death, initiation of new anticancer therapy, withdrawal of consent, loss to follow-up, or study completion; assessed every 4 weeks (±7 days).
The proportion of efficacy-evaluable participants whose best overall response is complete response (CR) or partial response (PR), as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR is calculated as the number of participants with CR or PR divided by the total number of efficacy-evaluable participants.
Incidence of Treatment-Related Grade 2 or Higher Peripheral Neuropathy
Time frame: From the first dose of study treatment through the end of study treatment.
The proportion of participants in the safety analysis population who develop treatment-related Grade 2 or higher peripheral neuropathy during study treatment. Peripheral neuropathy will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 and may include peripheral sensory neuropathy, peripheral motor neuropathy, paresthesia, numbness, tingling, pain, burning sensation, hypoesthesia, muscle weakness, impaired fine motor function, or gait instability. Events will be considered treatment-related based on investigator assessment.
4 secondary outcomes
Incidence of Adverse Events and Serious Adverse Events
Time frame: From the first dose through the protocol-defined safety follow-up period; routine safety assessments through 28 days after the last dose, with SAE monitoring through 90 days after the last dose.
Disease Control Rate (DCR)
Time frame: From baseline until disease progression, death, initiation of new anticancer therapy, withdrawal of consent, loss to follow-up, or study completion; assessed every 4 weeks (±7 days).
Progression-Free Survival (PFS)
Time frame: From the first administration of study treatment until documented disease progression or death from any cause, whichever occurs first, through study completion.
Overall Survival (OS)
Time frame: From the first administration of study treatment until death from any cause, through study completion.
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 5 Nov 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.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
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 Disitamab Vedotin, Toripalimab and Cetirizine in people with Bladder Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 13 inclusion and 16 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 5 Nov 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From baseline until disease progression, death, initiation of new anticancer therapy, withdrawal of consent, loss to follow-up, or study completion; assessed every 4 weeks (±7 days).). The study lists 2 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 5 Nov 2026.