Muscle Invasive Bladder Cancer (MIBC)Phase 2HARBORNCT07296705
Neoadjuvant Zanidatamab + Tislelizumab + Chemotherapy for Selective Bladder Preservation in HER2-Positive MIBC
A Phase 2 study testing Zanidatamab, Tislelizumab and Cisplatin in people with Muscle Invasive Bladder Cancer (MIBC), run by Fujian Medical University Union Hospital at 12 sites in China.
Trial summary
This is a multicenter, open-label, prospective, single-arm, phase II study designed to evaluate the efficacy and safety of neoadjuvant zanidatamab combined with tislelizumab and chemotherapy, followed by selective bladder preservation, in patients with HER2-positive muscle-invasive bladder cancer (MIBC) staged… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Muscle Invasive Bladder Cancer (MIBC)
- What is being tested?
- Zanidatamab, Tislelizumab and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 12 sitesChina
- Study dates
- 25 Oct 2025to Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate, able to provide written informed consent, and able to understand and comply with study requirements and the assessment schedule.
- Age 18 to 85 years on the date of informed consent.
- Residual disease after TURBT; histologically confirmed urothelial carcinoma of the bladder staged cT2-T4aN0-1M0 per AJCC 8th edition by histology and imaging. For mixed histology, urothelial carcinoma must be predominant (≥50%).
- Availability of TURBT tumor tissue and corresponding pathology report; either fresh surgical tissue or unstained slides may be submitted.
- HER2-positive: IHC 2+ or 3+.
- No prior anti-HER2-directed therapy (including but not limited to HER2 antibodies, HER2-targeting ADCs, or HER2-targeted TKIs) and no prior PD-(L)1 therapy.
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- ECOG performance status 0-2.
- Adequate organ function based on screening labs obtained ≤14 days before enrollment:
- For the following counts, no growth-factor support within 14 days prior to sample collection: i. Absolute neutrophil count ≥ 1.5 × 10^9/L ii. Platelets ≥ 100 × 10^9/L iii. Hemoglobin ≥ 90 g/L b. INR or aPTT ≤ 1.5 × upper limit of normal (ULN) c. Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert syndrome or isolated indirect hyperbilirubinemia) d. AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN
- Women of childbearing potential must have a negative urine or serum pregnancy test within ≤7 days before enrollment and agree to use highly effective contraception during the study and for ≥120 days after the last dose of zanidatamab, tislelizumab, or chemotherapy (whichever occurs later).
- Non-sterilized men must agree to use highly effective contraception during the study and for ≥120 days after the last dose of zanidatamab, tislelizumab, or chemotherapy (whichever occurs later).
Who cannot join
- Pregnant or breastfeeding women.
- Uncontrolled infection requiring systemic therapy.
- Diagnosis of another malignancy within the past 5 years.
- Major surgery or significant trauma within 28 days prior to enrollment (placement of a vascular access device and TURBT are not considered major surgery).
- Prior radiotherapy to the bladder for bladder cancer.
- Active autoimmune disease requiring systemic treatment that, in the investigator's judgment, would affect study therapy.
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- Any of the following cardiovascular criteria:
- Cardiac chest pain within ≤28 days before first study dose, defined as moderate pain that limits activities of daily living.
- Symptomatic pulmonary embolism within ≤28 days before first study dose.
- Any acute myocardial infarction within ≤6 months before first study dose.
- Any history of heart failure of New York Heart Association (NYHA) Class III or IV within ≤6 months before first study dose.
- Any ventricular arrhythmia of severity ≥ Grade 2 within ≤6 months before first study dose.
- Any cerebrovascular accident within ≤6 months before first study dose.
- Corrected QT interval (QTc by Fridericia): ≥470 msec for women or ≥450 msec for men.
- Note: If the initial ECG shows QTc >450 msec (men) or >470 msec (women), a follow-up ECG should be performed to confirm.
- Left ventricular ejection fraction (LVEF) ≤50% by multigated acquisition (MUGA) scan or echocardiography (ECHO). The same modality used at baseline must be used for follow-up assessments.
- History of acute myocardial infarction or ischemic stroke within 6 months.
- Human immunodeficiency virus (HIV) infection (i.e., positive antibodies to HIV-1/2), active syphilis infection, or active tuberculosis infection.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled pulmonary disease, including pulmonary fibrosis or acute lung disease.
- Known hypersensitivity to any study drug.
- Concurrent participation in another clinical study, unless observational (non-interventional) or in the follow-up phase of an interventional study.
- Any other condition deemed by the investigator to render the patient ineligible.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Shaoxing Zhu, MD, 86-18758872716, zsx2005@126.com
- Recruiting
Fujian Provincial Hospital Affiliated to Fuzhou University
Fuzhou, Fujian, 350001
Qingguo Zhu, 86-13115910047, zuqinguo@163.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Jinchao Chen, 86-13758124230, runner421@126.com
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Jiasheng Bian, 86-15954104097, sdbjs232466@sina.com
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Xinhua Tu, 86-13870628187, Tuxinhua2020@163.com
- Recruiting
Affiliated Hospital of Putian University
Putian, Fujian, 351106
Guowei Lin, 86-13599013301, gwlin98@163.com
- Recruiting
Quanzhou First Hospital Affiliated to Fujian Medical University
Quanzhou, Fujian, 362002
Changde Fu, 86-15060456767, fucd352@163.com
- Recruiting
Sanming First Hospital
Sanming, Fujian, 365099
Dongming Lu, 86-18759888086, 944607396@qq.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Yijun Shen, 86-13817126663, yijunshen@urocancer.org
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325035
Hang Huang, 86-13738301029, huanghang163@163.com
- Recruiting
The First Affi liated Hospital of Xiamen University
Xiamen, Fujian, 361003
Zhun Wu, 86-15880217987, wuzhun2000@163.com
- Recruiting
Zhangzhou Affiliated Hospital to Fujian Medical University
Zhangzhou, Fujian, 363000
Zhiming Zhuang, 86-13709317819, drzzm@sina.com
About this study
Official title: Selective Bladder Preservation After Neoadjuvant Zanidatamab Combined With Tislelizumab and Chemotherapy in Patients With HER2-Positive Muscle-Invasive Bladder Cancer: A Multicenter Study
This is a multicenter, open-label, prospective, single-arm, phase II study designed to evaluate the efficacy and safety of neoadjuvant zanidatamab combined with tislelizumab and chemotherapy, followed by selective bladder preservation, in patients with HER2-positive muscle-invasive bladder cancer (MIBC) staged cT2-4aN0-1M0.
Read the detailed description
Eligible patients will receive neoadjuvant therapy with zanidatamab plus tislelizumab in combination with chemotherapy, followed by clinical reassessment. Patients who achieve a clinical complete response (cCR) will continue maintenance therapy with zanidatamab and tislelizumab. Patients who do not achieve cCR may, undergo radiotherapy or partial cystectomy and then continue maintenance zanidatamab plus tislelizumab; alternatively, they may proceed directly to radical cystectomy followed by adjuvant tislelizumab.
- Conditions
- Muscle Invasive Bladder Cancer (MIBC)
- Being tested
- Zanidatamab, Tislelizumab, Cisplatin, Gemcitabine, Nab-paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanidatamabDrug
Zanidatamab (1,800 mg for patients <70 kg or 2,400 mg for patients ≥70 kg, administered intravenously every 3 weeks) for 4 cycles is given as part of the neoadjuvant regimen. After completion of neoadjuvant therapy, disease status is reassessed. Patients achieving a clinical complete response (cCR) may continue zanidatamab every 3 weeks for 2-4 cycles as part of bladder-preserving treatment; those without cCR may receive radiotherapy or partial cystectomy followed by zanidatamab every 3 weeks for 2-4 cycles, or undergo radical cystectomy without further zanidatamab treatment.
TislelizumabDrug
Tislelizumab (200 mg administered intravenously every 3 weeks) is administered for 4 cycles as neoadjuvant therapy. After completion of 4 cycles, disease status is reassessed. Patients achieving a clinical complete response (cCR) may proceed with selective bladder preservation and continue tislelizumab every 3 weeks for 12 cycles; those without cCR may receive radiotherapy or partial cystectomy followed by tislelizumab every 3 weeks for 12 cycles, or undergo radical cystectomy with adjuvant tislelizumab every 3 weeks for 12 cycles.
CisplatinDrug
Cisplatin (70 mg/m² administered intravenously every 3 weeks ) for 4 cycles is included in the neoadjuvant chemotherapy regimen for eligible cisplatin-based chemotherapy.
GemcitabineDrug
Gemcitabine (1,000 mg/m² administered intravenously every 3 weeks) for 4 cycles is given as part of the neoadjuvant chemotherapy regimen for eligible cisplatin-based chemotherapy.
Nab-paclitaxelDrug
Nab-paclitaxel (125 mg/m² administered intravenously every 3 weeks) for 4 cycles is given as part of the neoadjuvant chemotherapy regimen for ineligible or refused cisplatin-based chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Zanidatamab; Drug: Tislelizumab; Drug: Cisplatin; Drug: Gemcitabine; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Complete Response (cCR) Rate
Proportion of participants achieving cCR at the end of neoadjuvant therapy, defined as no evidence of tumor on radiographic imaging, no residual tumor on diagnostic TURBT, and negative urine cytology
Measured: At the end of Cycle 4 of neoadjuvant therapy (each cycle is 21 days)
Secondary outcomes (8)
1-Year Bladder-Intact Disease-Free Survival (BI-DFS)
Percentage of participants who, within 12 months from the first neoadjuvant dose, have no local or regional recurrence, no distant metastasis, no bladder cancer-related death, and have not undergone radical cystectomy
Measured: From first neoadjuvant dose to 12 months
2-Year Bladder-Intact Disease-Free Survival (BI-DFS)
Percentage of participants who, within 24 months from the first neoadjuvant dose, have no local or regional recurrence, no distant metastasis, no bladder cancer-related death, and have not undergone radical cystectomy
Measured: From first neoadjuvant dose to 24 months
Local Recurrence Free Survival (LRFS)
Time from the first neoadjuvant dose to local recurrence or death from any cause; participants without an event will be censored at last follow-up
Measured: From first neoadjuvant dose until event, assess up to 3 years
Distant Metastasis Free Survival (DMFS)
Time from the first neoadjuvant dose to distant metastasis or death from any cause; participants without an event will be censored at last follow-up
Measured: From first neoadjuvant dose until event, assess up to 3 years
Overall Survival (OS)
Time from the first neoadjuvant dose to death from any cause; participants alive at analysis will be censored at last follow-up.
Measured: From first neoadjuvant dose until death, assess up to 3 years
Safety and Adverse Events
Summary of study drug exposure (duration and dose) and adverse events
Measured: From first dose through last follow-up, assess up to 3 years
Quality of Life Assessed by EORTC QLQ-C30
To assess changes in overall and cancer-specific quality of life (QoL) from baseline to post-treatment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) in patients with HER2-positive MIBC receiving neoadjuvant and selective bladder-preserving therapy.
Measured: From baseline through last follow-up, assess up to 3 years
Quality of Life Assessed by FACT-BI
To assess changes in bladder cancer-specific quality of life (QoL) from baseline to post-treatment using the Functional Assessment of Cancer Therapy-Bladder (FACT-BI) questionnaire in patients with HER2-positive MIBC receiving neoadjuvant and selective bladder-preserving therapy.
Measured: From baseline through last follow-up, assess 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 posted22 Dec 2025
- Study start25 Oct 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 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.
- More trials run by Fujian Medical University Union HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BeiGene
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296705
- Sponsor's protocol ID
- HARBOR-II-2025
- Acronym
- HARBOR
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 22 Dec 2025
- Results posted
- 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 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Bladder Preservation After Neoadjuvant Zanidatamab Combined With Tislelizumab and Chemotherapy in Patients With HER2-Positive Muscle-Invasive Bladder Cancer: A Multicenter Study
- ClinicalTrials.gov ID
- NCT07296705
- Acronym / sponsor ID
- HARBOR / HARBOR-II-2025
- Conditions
- Muscle Invasive Bladder Cancer (MIBC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Collaborators
- BeiGene
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 Dec 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 is a multicenter, open-label, prospective, single-arm, phase II study designed to evaluate the efficacy and safety of neoadjuvant zanidatamab combined with tislelizumab and chemotherapy, followed by selective bladder preservation, in patients with HER2-positive muscle-invasive bladder cancer (MIBC) staged cT2-4aN0-1M0.
Detailed description
Eligible patients will receive neoadjuvant therapy with zanidatamab plus tislelizumab in combination with chemotherapy, followed by clinical reassessment. Patients who achieve a clinical complete response (cCR) will continue maintenance therapy with zanidatamab and tislelizumab. Patients who do not achieve cCR may, undergo radiotherapy or partial cystectomy and then continue maintenance zanidatamab plus tislelizumab; alternatively, they may proceed directly to radical cystectomy followed by adjuvant tislelizumab.
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: Zanidatamab, Drug: Tislelizumab, Drug: Cisplatin, Drug: Gemcitabine, Drug: Nab-paclitaxel |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Willing to participate, able to provide written informed consent, and able to understand and comply with study requirements and the assessment schedule.
- Age 18 to 85 years on the date of informed consent.
- Residual disease after TURBT; histologically confirmed urothelial carcinoma of the bladder staged cT2-T4aN0-1M0 per AJCC 8th edition by histology and imaging. For mixed histology, urothelial carcinoma must be predominant (≥50%).
- Availability of TURBT tumor tissue and corresponding pathology report; either fresh surgical tissue or unstained slides may be submitted.
- HER2-positive: IHC 2+ or 3+.
Key exclusion criteria (23 listed)
- Pregnant or breastfeeding women.
- Uncontrolled infection requiring systemic therapy.
- Diagnosis of another malignancy within the past 5 years.
- Major surgery or significant trauma within 28 days prior to enrollment (placement of a vascular access device and TURBT are not considered major surgery).
- Prior radiotherapy to the bladder for bladder cancer.
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 |
|---|---|---|
| ZanidatamabZanidatamab (1,800 mg for patients <70 kg or 2,400 mg for patients ≥70 kg, administered intravenously every 3 weeks) for 4 cycles is given as part of the neoadjuvant regimen. After completion of neoadjuvant therapy, disease status is reassessed. Patients achieving a clinical complete response (cCR) may continue zanidatamab every 3 weeks for 2-4 cycles as part of bladder-preserving treatment; those without cCR may receive radiotherapy or partial cystectomy followed by zanidatamab every 3 weeks for 2-4 cycles, or undergo radical cystectomy without further zanidatamab treatment. | Drug | Experimental group |
| TislelizumabTislelizumab (200 mg administered intravenously every 3 weeks) is administered for 4 cycles as neoadjuvant therapy. After completion of 4 cycles, disease status is reassessed. Patients achieving a clinical complete response (cCR) may proceed with selective bladder preservation and continue tislelizumab every 3 weeks for 12 cycles; those without cCR may receive radiotherapy or partial cystectomy followed by tislelizumab every 3 weeks for 12 cycles, or undergo radical cystectomy with adjuvant tislelizumab every 3 weeks for 12 cycles. | Drug | Experimental group |
| CisplatinCisplatin (70 mg/m² administered intravenously every 3 weeks ) for 4 cycles is included in the neoadjuvant chemotherapy regimen for eligible cisplatin-based chemotherapy. | Drug | Experimental group |
| GemcitabineGemcitabine (1,000 mg/m² administered intravenously every 3 weeks) for 4 cycles is given as part of the neoadjuvant chemotherapy regimen for eligible cisplatin-based chemotherapy. | Drug | Experimental group |
| Nab-paclitaxelNab-paclitaxel (125 mg/m² administered intravenously every 3 weeks) for 4 cycles is given as part of the neoadjuvant chemotherapy regimen for ineligible or refused cisplatin-based chemotherapy. | Drug | Experimental group |
Primary outcome
Clinical Complete Response (cCR) Rate
Time frame: At the end of Cycle 4 of neoadjuvant therapy (each cycle is 21 days)
Proportion of participants achieving cCR at the end of neoadjuvant therapy, defined as no evidence of tumor on radiographic imaging, no residual tumor on diagnostic TURBT, and negative urine cytology
8 secondary outcomes
1-Year Bladder-Intact Disease-Free Survival (BI-DFS)
Time frame: From first neoadjuvant dose to 12 months
2-Year Bladder-Intact Disease-Free Survival (BI-DFS)
Time frame: From first neoadjuvant dose to 24 months
Local Recurrence Free Survival (LRFS)
Time frame: From first neoadjuvant dose until event, assess up to 3 years
Distant Metastasis Free Survival (DMFS)
Time frame: From first neoadjuvant dose until event, assess up to 3 years
Overall Survival (OS)
Time frame: From first neoadjuvant dose until death, assess up to 3 years
Safety and Adverse Events
Time frame: From first dose through last follow-up, assess up to 3 years
Quality of Life Assessed by EORTC QLQ-C30
Time frame: From baseline through last follow-up, assess up to 3 years
Quality of Life Assessed by FACT-BI
Time frame: From baseline through last follow-up, assess up to 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 22 Dec 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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanidatamab, Tislelizumab and Cisplatin in people with Muscle Invasive Bladder Cancer (MIBC), run by Fujian Medical University Union Hospital at 12 sites 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 23 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: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Contact Shaoxing Zhu, MD (86-18758872716, zsx2005@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Complete Response (cCR) Rate (time frame: At the end of Cycle 4 of neoadjuvant therapy (each cycle is 21 days)). 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 22 Dec 2025.