Her2 Overexpressing High-Risk Non-Muscle Invasive Bladder Urothelial CarcinomaPhase 2NCT05495724
Disitamab Vedotin Combined With Tislelizumab for Her2 Overexpressing High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable
A Phase 2 study testing Disitamab Vedotin Tislelizumab and Disitamab Vedotin in people with Her2 Overexpressing High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
This is a phase II study to determine the safety and efficacy of Disitamab Vedotin when given in combination with Tislelizumab as treatment for patients with Her2 overexpressing high-risk non-muscle-invasive bladder cancer (HR NMIBC) which is not completely resectable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Her2 Overexpressing High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma
- What is being tested?
- Disitamab Vedotin Tislelizumab and Disitamab Vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2021to Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years;
- Urothelial carcinoma with Her2 IHC 2+ or 3+;
- High-risk non-muscle-invasive urothelial carcinoma or high-risk non-muscle-invasive urothelial carcinoma as the main pathological component > 50%, difined as following:
- T1 b. High-grade Ta c.Carcinoma in situ(CIS);
- Multi-point biopsy of bladder shows there are more than 2 section and over 3 points of pathological specimens are diagnosed as above, meanwhile, the tumor has to be diagnosed as not completely resectable by at least 2 senior urologist;
- Agreed to provide tissue examination samples (for detection of PD-L1 expression, tumor mutation load, IHC, detection of DNA and RNA, etc;)
Show all 11Show fewer
- Organ function level must meet or under the support treatment meet the following requirements:
- Hematological indexes: neutrophil count >= 1.5x10^9/L, platelet count >= 100x10^9/L, hemoglobin >= 9.0 g/dl;
- Liver function: total bilirubin <=1.5 ULN, alanine aminotransferase and aspartate aminotransferase <=2.5 ULN（patient with metastatic liver cancer：aminotransferase <=5.0 ULN）;
- Renal function: creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance ≥ 50 ml/min;
- The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up;
Who cannot join
- Active, known or suspected autoimmune diseases;
- History of primary immunodeficiency;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Pregnant or lactating female patients;
- Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions;
- Prior use of immunosuppressive drugs within 4 weeks prior to the start of treatment, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e. not more than 10 mg / day prednisolone or other corticosteroids with the same physiological dose);
Show all 15Show fewer
- Known or suspected allergy to disitamab vedotin or tislelizumab;
- Have a clear history of active tuberculosis;
- Participating in other clinical researchers;
- Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures;
- Uncontrolled concurrent diseases, including but not limited to:
- HIV infected (HIV antibody positive);
- Severe infection in active stage or poorly controlled;
- Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment]);
- Patients with active bleeding or new thrombotic disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, 300211
Hailong Hu, +86-13662096232, hhllove2004@163.com
Hailong Hu, MD,PhD
About this study
Official title: An Open Label, Phase 2 Study of Disitamab Vedotin Combined With Tislelizumab for Patients With Her2 Overexpressing (IHC2+ or 3+) High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable
This is a phase II study to determine the safety and efficacy of Disitamab Vedotin when given in combination with Tislelizumab as treatment for patients with Her2 overexpressing high-risk non-muscle-invasive bladder cancer (HR NMIBC) which is not completely resectable. Patients will receive treatment with Disitamab Vedotin in combination with tislelizumab every 3 weeks for 4 treatment cycles over 12 weeks followed by transurethral resection biopsy.
- Being tested
- Disitamab Vedotin Tislelizumab, Disitamab Vedotin
- Keywords
- Disitamab Vedotin, Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin TislelizumabDrug
Also called KEYNOTE-057
Disitamab Vedotin 120mg will be administered on Day 1 of each cycle for 4 treatment cycles;Tislelizumab 200mg will be administered on Day 2 of each cycle for 4 treatment cycles.
Disitamab VedotinDrug
Disitamab Vedotin
| Study group | Role | What they receive |
|---|---|---|
| Disitamab Vedotin and Tislelizumab | Experimental | Disitamab Vedotin 120mg IV on day 1 in combination with Tislelizumab 200mg IV on day 2 every 3 weeks for 3 or 4 cycles followed by transurethral resection biopsy. Receives: Drug: Disitamab Vedotin Tislelizumab |
| Disitamab Vedotin | Other | Disitamab Vedotin 120mg IV on day 1 every 3 weeks for 3 or 4 cycles followed by transurethral resection biopsy. Receives: Drug: Disitamab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate
Measured: At the time of transurethral resection biopsy (within 9 or 12 weeks of the first dose of disitamab vedotin)
Secondary outcomes (8)
Progress Free Survival（PFS）
Measured: up to 3 years
Recurrence Free Survival（RFS）
Measured: up to 3 years
Cystectomy-Free Survival (CFS)
defined from D1 of treatment until cystectomy
Measured: up to 3 years
Duration of Response (DOR)
Measured: up to 3 years
Event-Free Survival（EFS）
defined from D1 of treatment until the time of any events，included progressive disease，discontinue treatment for any cause or death
Measured: up to 3 years
Number of adverse events and severity by grade (CTCAE)
Safety and toxicity will be characterized according to the reported adverse event (AE) profile using NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0, as well as a patient questionnaire derived from the Patient Reported Outcomes (PRO)-CTCAE and Patient Reported Outcomes Measurement Information System (PROMIS).
Measured: 12 weeks of treatment plus 30 days for toxicity followup
Her2 status
Measured: up to 3 years
PD-1 expression status
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start23 Jul 2021
- Primary completionFeb 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Her2 Overexpressing High-Risk Non-Muscle Invasive Bladder Urothelial CarcinomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hailong Hu, Principal investigator, Tianjin Medical University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495724
- Sponsor's protocol ID
- TRUCE-04
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qie Y, Jia K, Huang S, Zhao J, Xue Z, Guo S, Zhang T, Wu Z, Shen C, Hu H. Disitamab Vedotin Plus Tislelizumab in Transurethrally Unresectable, ERBB2-Positive, Non-Muscle-Invasive Bladder Cancer: A Nonrandomized Clinical Trial. JAMA Oncol. 2026 Oct 8:e263909. doi: 10.1001/jamaoncol.2026.3909. Online ahead of print.
PubMed 42848391
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase 2 Study of Disitamab Vedotin Combined With Tislelizumab for Patients With Her2 Overexpressing (IHC2+ or 3+) High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable
- ClinicalTrials.gov ID
- NCT05495724
- Acronym / sponsor ID
- TRUCE-04
- Keywords
- Disitamab Vedotin, Tislelizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 10 Aug 2022 (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 phase II study to determine the safety and efficacy of Disitamab Vedotin when given in combination with Tislelizumab as treatment for patients with Her2 overexpressing high-risk non-muscle-invasive bladder cancer (HR NMIBC) which is not completely resectable. Patients will receive treatment with Disitamab Vedotin in combination with tislelizumab every 3 weeks for 4 treatment cycles over 12 weeks followed by transurethral resection biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disitamab Vedotin and Tislelizumab | Experimental | Drug: Disitamab Vedotin TislelizumabDisitamab Vedotin 120mg IV on day 1 in combination with Tislelizumab 200mg IV on day 2 every 3 weeks for 3 or 4 cycles followed by transurethral resection biopsy. |
| Disitamab Vedotin | Other | Drug: Disitamab VedotinDisitamab Vedotin 120mg IV on day 1 every 3 weeks for 3 or 4 cycles followed by transurethral resection biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years;
- Urothelial carcinoma with Her2 IHC 2+ or 3+;
- High-risk non-muscle-invasive urothelial carcinoma or high-risk non-muscle-invasive urothelial carcinoma as the main pathological component > 50%, difined as following:
- Multi-point biopsy of bladder shows there are more than 2 section and over 3 points of pathological specimens are diagnosed as above, meanwhile, the tumor has to be diagnosed as not completely resectable by at least 2 senior urologist;
- Agreed to provide tissue examination samples (for detection of PD-L1 expression, tumor mutation load, IHC, detection of DNA and RNA, etc;)
Key exclusion criteria (15 listed)
- Active, known or suspected autoimmune diseases;
- History of primary immunodeficiency;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Pregnant or lactating female patients;
- Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions;
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 Vedotin TislelizumabAlso: KEYNOTE-057Disitamab Vedotin 120mg will be administered on Day 1 of each cycle for 4 treatment cycles;Tislelizumab 200mg will be administered on Day 2 of each cycle for 4 treatment cycles. | Drug | Disitamab Vedotin and Tislelizumab |
| Disitamab VedotinDisitamab Vedotin | Drug | Disitamab Vedotin |
Primary outcome
Complete Response (CR) Rate
Time frame: At the time of transurethral resection biopsy (within 9 or 12 weeks of the first dose of disitamab vedotin)
8 secondary outcomes
Progress Free Survival（PFS）
Time frame: up to 3 years
Recurrence Free Survival（RFS）
Time frame: up to 3 years
Cystectomy-Free Survival (CFS)
Time frame: up to 3 years
Duration of Response (DOR)
Time frame: up to 3 years
Event-Free Survival（EFS）
Time frame: up to 3 years
Number of adverse events and severity by grade (CTCAE)
Time frame: 12 weeks of treatment plus 30 days for toxicity followup
Her2 status
Time frame: up to 3 years
PD-1 expression status
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Derived from this study: PubMed 42848391Qie Y, Jia K, Huang S, Zhao J, Xue Z, Guo S, Zhang T, Wu Z, Shen C, Hu H. Disitamab Vedotin Plus Tislelizumab in Transurethrally Unresectable, ERBB2-Positive, Non-Muscle-Invasive Bladder Cancer: A Nonrandomized Clinical Trial. JAMA Oncol. 2026 Oct 8:e263909. doi: 10.1001/jamaoncol.2026.3909. Online ahead of print.
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. This study is not recruiting at the moment.
Hailong Hu principal investigator
Tianjin Medical University Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Disitamab Vedotin Tislelizumab and Disitamab Vedotin in people with Her2 Overexpressing High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma, run by Tianjin Medical University Second Hospital 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 11 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: status not confirmed, as of the sponsor's last update on 10 Aug 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hailong Hu (+86-13662096232, hhllove2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) Rate (time frame: At the time of transurethral resection biopsy (within 9 or 12 weeks of the first dose of disitamab vedotin)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495724, which also lists 1 linked publication.
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 10 Aug 2022.