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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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.

Shaoxing Zhu, MD contact

86-18758872716

zsx2005@126.com

12 sites in 1 country

China12 sites, 12 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

    Recruiting

Other trials in China

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.

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 groups in NCT07296705
Study groupRoleWhat they receive
Experimental groupExperimentalNot 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.

  1. 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. 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. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted22 Dec 2025
  2. Study start25 Oct 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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)
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

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.

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