Muscle-Invasive Bladder Cancer (MIBC)Phase 2NCT07624201
Trastuzumab Rezetecan and Adebrelimab as Neoadjuvant Therapy for HER2-Positive Muscle-Invasive Bladder Cancer
A Phase 2 study testing Trastuzumab Rezetecan Combined with Adebelizumab in people with Muscle-Invasive Bladder Cancer (MIBC), run by Harbin Medical University at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of neoadjuvant trastuzumab rezetecan combined with adebrelimab for the treatment of HER2-positive muscle-invasive bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-Invasive Bladder Cancer (MIBC)
- What is being tested?
- Trastuzumab Rezetecan Combined with Adebelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Jun 2029
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- ECOG performance status of 0 or 1.
- Histopathologically diagnosed muscle-invasive bladder cancer (MIBC) (cT2-T4a, N0-1, M0).
- Tumor tissue with HER2 expression (IHC 2+ or 3+) and suitable for radical cystectomy (RC) and transurethral resection of bladder tumor (TURBT).
- No prior systemic chemotherapy.
- At least one measurable lesion per RECIST v1.1 (spiral CT long diameter ≥10 mm or short diameter of enlarged lymph node ≥15 mm) before diagnostic surgery.
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- Adequate organ function (no transfusion or hematopoietic growth factor within 2 weeks before blood count screening):
- ANC ≥1.5×10⁹/L
- PLT ≥100×10⁹/L
- Hb ≥90 g/L
- TBIL ≤1.5×ULN (except subjects with Gilbert's syndrome)
- ALT and AST ≤2.5×ULN
- Cr ≤1.5×ULN
- LVEF ≥50%
- QTcF ≤450 ms
- Females of childbearing potential must agree to abstain from heterosexual intercourse or use reliable, effective contraception from signing informed consent until at least 120 days after the last dose of study drug; serum HCG must be negative within 7 days before starting study treatment; and must be non-lactating.
- A female is considered of childbearing potential if she has reached menarche, is not postmenopausal (≥12 consecutive months of amenorrhea without other cause), and has not undergone sterilization surgery (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
- Male patients with partners of childbearing potential must agree to abstain from heterosexual intercourse or use reliable, effective contraception from signing informed consent until at least 120 days after the last dose of study drug. During the same period, male subjects must also agree not to donate sperm. Male subjects with pregnant partners must use a condom and no additional contraception is required.
- Subjects voluntarily join the study, sign written informed consent, and are expected to have good compliance with the study protocol.
Who cannot join
- Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, etc.); patients with vitiligo; patients with childhood asthma that has completely resolved and requires no intervention in adulthood may be included; patients with asthma requiring bronchodilators for medical intervention are excluded.
- Patients currently using immunosuppressants or systemic corticosteroids for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent) and continuing use within 2 weeks before the first dose.
- History of severe allergic reactions to other monoclonal antibodies.
- Subjects with untreated central nervous system (CNS) metastases; subjects who have received prior systemic, radical treatment for brain or leptomeningeal metastases (radiotherapy or surgery) may be included if imaging confirms stability for at least 1 month, systemic corticosteroid therapy (dose >10 mg/day prednisone or equivalent) has been discontinued for more than 2 weeks, and they are asymptomatic.
- Hypertension that cannot be well controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
- Poorly controlled cardiac clinical symptoms or diseases, including: 1) NYHA class ≥2 heart failure; 2) unstable angina; 3) myocardial infarction within 1 year; 4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 5) QTc >450 ms (male) or QTc >470 ms (female); 6) Left ventricular ejection fraction (LVEF) ≤50% (i.e., EF >50% is required for inclusion).
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- Abnormal coagulation function (INR >2.0, PT >16 s), bleeding tendency, or currently receiving thrombolytic or anticoagulant therapy; prophylactic use of low-dose aspirin or low molecular weight heparin is permitted.
- Bleeding events of grade ≥2 per CTCAE v6.0 within 4 weeks before the first dose.
- Imaging shows tumor invasion into major blood vessels, or the investigator judges that the tumor has a very high possibility of invading major blood vessels during treatment, leading to fatal massive hemorrhage.
- Arterial/venous thrombotic events within 6 months before the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
- Patients who received prior chemotherapy (including platinum-based chemotherapy) or surgery less than 4 weeks before study drug administration; palliative radiotherapy less than 2 weeks before study drug administration; molecular targeted therapy (including other oral targeted drugs in clinical trials) within less than 5 half-lives before the first study drug dose, or prior treatment-related adverse events (excluding alopecia) not recovered to ≤CTCAE grade 1.
- Patients with radiation enteritis caused by pelvic radiotherapy within 12 months before study drug administration.
- Active infection, unexplained fever ≥38.5°C within 7 days before dosing, or baseline white blood cell count >15×10⁹/L.
- Known history or evidence of interstitial lung disease or non-infectious pneumonitis that has required corticosteroid therapy; or patients who may interfere with the detection or management of suspected drug-related pulmonary toxicity.
- History of immunodeficiency, including positive HIV serology, or other acquired or congenital immunodeficiency diseases, or known active tuberculosis.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV reference: HBsAg positive and HBV DNA ≥500 IU/ml; HCV reference: HCV antibody positive and HCV viral load > upper limit of normal).
- Patients with another malignancy within the past 5 years or concurrently (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; for patients with recurrent ovarian cancer with prior history of breast cancer, those with no recurrence for >3 years after radical breast cancer surgery are excluded).
- Prior treatment with anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulatory or checkpoint pathways).
- Receipt of live vaccine within 4 weeks before the first dose or possible receipt during the study period.
- Pregnant or breastfeeding female patients.
- Patients judged by the investigator to have other conditions that may affect the conduct of the clinical study, inability to comply with the protocol, or lack of cooperation, or patients at risk of study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Trastuzumab Rezetecan and Adebrelimab for HER2-positive Muscle-invasive Bladder Cancer: a Phase II, Prospective, Single-arm, Multicenter Trial
This study aims to evaluate the efficacy and safety of neoadjuvant trastuzumab rezetecan combined with adebrelimab for the treatment of HER2-positive muscle-invasive bladder cancer.
Read the detailed description
Bladder cancer is an aggressive malignancy with a poor prognosis, ranking 13th globally in cancer incidence and first among urological tumors in China, with an increasing trend observed in urban cancer surveillance. Traditional treatments, including radical cystectomy and platinum-based chemotherapy, have limitations such as chemotherapy resistance and reduced postoperative quality of life. Recently, immune checkpoint inhibitors and antibody-drug conjugates (ADCs) have become research hotspots. This prospective, single-arm, multicenter clinical study aims to preliminarily evaluate the efficacy and safety of Trastuzumab Rezetecan combined with Adebrelimab as neoadjuvant therapy for HER2-expressing muscle-invasive bladder cancer (MIBC). A total of 58 eligible patients will be enrolled. The study includes screening, neoadjuvant treatment, and follow-up periods. During screening, untreated HER2-expressing MIBC patients eligible for radical surgery will be enrolled, with the period from informed consent to first dose not exceeding 28 days. The neoadjuvant treatment consists of Trastuzumab Rezetecan 3.2 mg/kg Q3W and Adebrelimab 1200 mg Q3W for three cycles. Patients will undergo imaging and surgical assessment 3-4 weeks after the last neoadjuvant treatment; those meeting surgical criteria will receive either transurethral resection or radical cystectomy. In the follow-up period, patients who proceed to surgery after neoadjuvant treatment will undergo postoperative safety monitoring and long-term survival follow-up.
- Conditions
- Muscle-Invasive Bladder Cancer (MIBC)
- Being tested
- Trastuzumab Rezetecan Combined with Adebelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab Rezetecan Combined with AdebelizumabDrug
Trastuzumab Rezetecan 3.2 mg/kg, Q3W, in combination with Adebrelimab 1200 mg, Q3W, for a total of 3 cycles. Subjects will undergo preoperative imaging and surgical eligibility assessment at 3-4 weeks after the last dose of neoadjuvant therapy. Those who meet the surgical criteria will receive either transurethral resection or radical resection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Trastuzumab Rezetecan Combined with Adebelizumab Receives: Drug: Trastuzumab Rezetecan Combined with Adebelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response
Assessed by pathological evaluation of resected bladder cancer specimens after neoadjuvant therapy, defined as the proportion of patients with no residual tumor (pT0N0).
Measured: Assessed post-surgery (radical cystectomy or TURBT) on resected tumor specimens after neoadjuvant therapy. Measured postoperatively, up to approximately 4 months after treatment start.
Secondary outcomes (7)
Clinical Complete Response Rate
Assessed by preoperative imaging (CT/MRI) and urine cytology after neoadjuvant therapy, defined as the proportion of patients with no residual tumor on imaging, negative urine cytology, and no evidence of nodal or distant metastasis.
Measured: Assessed by preoperative imaging and surgical evaluation at 3-4 weeks after the last neoadjuvant dose. Up to approximately 4 months after treatment start.
Pathological Downstaging Rate
Assessed by postoperative pathological staging, defined as the proportion of patients with ypT < T2 and ypN = N0 after neoadjuvant therapy.
Measured: Assessed simultaneously with pCR on postoperative pathological staging. Up to approximately 4 months after treatment start.
Event-Free Survival
Time from first dose to first occurrence of disease progression, recurrence, second primary tumor, or death from any cause.
Measured: Time from treatment start to first occurrence of disease progression, recurrence, second primary tumor, or death. Continuously assessed during follow-up, maximum follow-up of 36 months.
Overall Survival
Time from first dose to death from any cause.
Measured: Time from treatment start to death from any cause. Continuously assessed, maximum follow-up of 36 months.
QoL Score
Assessed using the EORTC QLQ-C30 V3.0 patient-reported questionnaire at screening, each treatment cycle, end of treatment, and follow-up visits.
Measured: Assessed by EORTC QLQ-C30 V3.0 at screening, Day 1 of each 21-day cycle (3 cycles), pre-surgery, post-surgery q30d ×3, then q3m (Year 1) and q6m (Years 2-3), up to 36 months.
Adverse event incidence
AEs and laboratory abnormalities graded by NCI CTCAE v6.0; SAEs recorded separately; surgical endpoints (feasibility, delay/cancellation rate, procedure change, operation duration) collected from postoperative clinical records and surgical logs.
Measured: AEs/SAEs/lab abnormalities collected from informed consent to 30 days post-last dose (safety follow-up). Surgical endpoints assessed postoperatively. Only treatment-related SAEs collected during survival follow-up, up to 36 months.
Exploratory Biomarkers
Blood and tumor tissue samples collected at baseline, during treatment, and at end of treatment to assess PD-L1, HER2, and other markers for correlation with efficacy (e.g., pCR, EFS).
Measured: Blood and tumor samples at baseline, C2D1, C3D1 (21-day cycles), at progression, and at EOT (after 3 cycles/pre-surgery). Max collection ~4 months; no routine survival follow-up sampling.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-Invasive Bladder Cancer (MIBC)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The Fourth Affiliated Hospital of China Medical University, Jilin Provincial Tumor Hospital, Tianjin Medical University Second Hospital, First Hospital of China Medical University
- Responsible party
- Principal investigator, Xu Yangyang, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624201
- Sponsor's protocol ID
- SHR-A1811-1316-BC
- Status last verified
- Oct 2026
- First submitted
- 21 May 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Trastuzumab Rezetecan and Adebrelimab for HER2-positive Muscle-invasive Bladder Cancer: a Phase II, Prospective, Single-arm, Multicenter Trial
- ClinicalTrials.gov ID
- NCT07624201
- Acronym / sponsor ID
- SHR-A1811-1316-BC
- Conditions
- Muscle-Invasive Bladder Cancer (MIBC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- The Fourth Affiliated Hospital of China Medical University, Jilin Provincial Tumor Hospital, Tianjin Medical University Second Hospital, First Hospital of China Medical University
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 3 Jun 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 aims to evaluate the efficacy and safety of neoadjuvant trastuzumab rezetecan combined with adebrelimab for the treatment of HER2-positive muscle-invasive bladder cancer.
Detailed description
Bladder cancer is an aggressive malignancy with a poor prognosis, ranking 13th globally in cancer incidence and first among urological tumors in China, with an increasing trend observed in urban cancer surveillance. Traditional treatments, including radical cystectomy and platinum-based chemotherapy, have limitations such as chemotherapy resistance and reduced postoperative quality of life. Recently, immune checkpoint inhibitors and antibody-drug conjugates (ADCs) have become research hotspots. This prospective, single-arm, multicenter clinical study aims to preliminarily evaluate the efficacy and safety of Trastuzumab Rezetecan combined with Adebrelimab as neoadjuvant therapy for HER2-expressing muscle-invasive bladder cancer (MIBC). A total of 58 eligible patients will be enrolled. The study includes screening, neoadjuvant treatment, and follow-up periods. During screening, untreated HER2-expressing MIBC patients eligible for radical surgery will be enrolled, with the period from informed consent to first dose not exceeding 28 days. The neoadjuvant treatment consists of Trastuzumab Rezetecan 3.2 mg/kg Q3W and Adebrelimab 1200 mg Q3W for three cycles. Patients will undergo imaging and surgical assessment 3-4 weeks after the last neoadjuvant treatment; those meeting surgical criteria will receive either transurethral resection or radical cystectomy. In the follow-up period, patients who proceed to surgery after neoadjuvant treatment will undergo postoperative safety monitoring and long-term survival follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Trastuzumab Rezetecan Combined with AdebelizumabTrastuzumab Rezetecan Combined with Adebelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥18 years.
- ECOG performance status of 0 or 1.
- Histopathologically diagnosed muscle-invasive bladder cancer (MIBC) (cT2-T4a, N0-1, M0).
- Tumor tissue with HER2 expression (IHC 2+ or 3+) and suitable for radical cystectomy (RC) and transurethral resection of bladder tumor (TURBT).
- No prior systemic chemotherapy.
Key exclusion criteria (21 listed)
- Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, etc.); patients with vitiligo; patients with childhood asthma that has completely resolved and requires no intervention in adulthood may be included; patients with asthma requiring bronchodilators for medical intervention are excluded.
- Patients currently using immunosuppressants or systemic corticosteroids for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent) and continuing use within 2 weeks before the first dose.
- History of severe allergic reactions to other monoclonal antibodies.
- Subjects with untreated central nervous system (CNS) metastases; subjects who have received prior systemic, radical treatment for brain or leptomeningeal metastases (radiotherapy or surgery) may be included if imaging confirms stability for at least 1 month, systemic corticosteroid therapy (dose >10 mg/day prednisone or equivalent) has been discontinued for more than 2 weeks, and they are asymptomatic.
- Hypertension that cannot be well controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
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 |
|---|---|---|
| Trastuzumab Rezetecan Combined with AdebelizumabTrastuzumab Rezetecan 3.2 mg/kg, Q3W, in combination with Adebrelimab 1200 mg, Q3W, for a total of 3 cycles. Subjects will undergo preoperative imaging and surgical eligibility assessment at 3-4 weeks after the last dose of neoadjuvant therapy. Those who meet the surgical criteria will receive either transurethral resection or radical resection. | Drug | Experimental Group |
Primary outcome
Pathological Complete Response
Time frame: Assessed post-surgery (radical cystectomy or TURBT) on resected tumor specimens after neoadjuvant therapy. Measured postoperatively, up to approximately 4 months after treatment start.
Assessed by pathological evaluation of resected bladder cancer specimens after neoadjuvant therapy, defined as the proportion of patients with no residual tumor (pT0N0).
7 secondary outcomes
Clinical Complete Response Rate
Time frame: Assessed by preoperative imaging and surgical evaluation at 3-4 weeks after the last neoadjuvant dose. Up to approximately 4 months after treatment start.
Pathological Downstaging Rate
Time frame: Assessed simultaneously with pCR on postoperative pathological staging. Up to approximately 4 months after treatment start.
Event-Free Survival
Time frame: Time from treatment start to first occurrence of disease progression, recurrence, second primary tumor, or death. Continuously assessed during follow-up, maximum follow-up of 36 months.
Overall Survival
Time frame: Time from treatment start to death from any cause. Continuously assessed, maximum follow-up of 36 months.
QoL Score
Time frame: Assessed by EORTC QLQ-C30 V3.0 at screening, Day 1 of each 21-day cycle (3 cycles), pre-surgery, post-surgery q30d ×3, then q3m (Year 1) and q6m (Years 2-3), up to 36 months.
Adverse event incidence
Time frame: AEs/SAEs/lab abnormalities collected from informed consent to 30 days post-last dose (safety follow-up). Surgical endpoints assessed postoperatively. Only treatment-related SAEs collected during survival follow-up, up to 36 months.
Exploratory Biomarkers
Time frame: Blood and tumor samples at baseline, C2D1, C3D1 (21-day cycles), at progression, and at EOT (after 3 cycles/pre-surgery). Max collection ~4 months; no routine survival follow-up sampling.
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 19 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Trastuzumab Rezetecan Combined with Adebelizumab in people with Muscle-Invasive Bladder Cancer (MIBC), run by Harbin Medical 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 19 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 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 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?
Pathological Complete Response (time frame: Assessed post-surgery (radical cystectomy or TURBT) on resected tumor specimens after neoadjuvant therapy. Measured postoperatively, up to approximately 4 months after treatment start.). 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 19 Oct 2026.