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Non-muscle Invasive Bladder CancerPhase 2NCT06187506

Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer

A Phase 2 study testing Disitamab vedotin and Bacillus Calmette Guerin Vaccine in people with Non-muscle Invasive Bladder Cancer and HER-2 Protein Overexpression, run by Fudan University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a prospective, open, single-center clinical study of the anti-HER2(Human epidermal growth factor receptor-2) ADC(antibody-drug conjugate) drug Disitamab Vedotin in combination with BCG(bacillus Calmette-Guerin) therapy in very high-risk NMIBC(Non-muscle invasive bladder cancer) patients with HER2 expression… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Disitamab vedotin and Bacillus Calmette Guerin Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
18 Dec 2023to Jan 2027
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;
  • Histologically confirmed non-muscle-invasive urothelial cell carcinoma (UCC) of the bladder; A.Histopathology: any variant of UCC, The presence of any lymphovascular infiltration (LVI) was considered evidence of high risk. B. Confined to the mucosal (Ta, Tis) and lamina propria layers (T1) of the bladder. In addition, subjects had all visible tumors removed as completely as possible prior to the first dose of study drug and documented at baseline cystoscopy. C. CIS(Carcinoma in situ) does not require complete resection, but coexisting papillary carcinoma must be removed as completely as possible prior to enrollment and documented at baseline cystoscopy. Negative urine cytology results against malignant tumor cells are not required.
  • Presence of HER2 expression (IHC 1+/2+/3+) by IHC in our pathology department;
  • VHR(Very high risk) NMIBC, defined as having at least 1 of the following: Multiple and/or large (greater than [>] 3 centimeters [cm]) T1, (HG/G3) tumors; T1, (HG/G3) tumor with concurrent CIS; T1, G3 with CIS in prostatic urethra; Micropapillary variant of non-muscle invasive urothelial carcinoma;
  • Received first dose of medication ≤ 12 weeks from first TURBT;
  • Refusal or unsuitability for radical cystectomy;
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  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (</=) 1;
  • Adequate hematologic and end-organ function, Creatinine clearance >/=30 milliliters per minute (mL/min) (calculated using the Cockcroft-Gault formula);
  • Subjects (or their legal representatives) must sign an informed consent form (ICF);
  • Females of childbearing potential must have a negative pregnancy test result (beta-hCG) (urine or serum) within 7 days prior to the first dose of study drug.

Who cannot join

  • Evidence of locally advanced, metastatic, muscle-invasive, and/or extravesical bladder cancer;
  • Upper urinary tract urothelial carcinoma(UTIC), except 2 years without recurrence after previous radical UTUC;
  • Histopathologic examination reveals any small cell component of the bladder, simple adenocarcinoma, simple squamous cell carcinoma or simple squamous CIS;
  • Previously received other anti-HER-2 therapy;
  • Active malignancy outside of the disease being treated by the study (i.e., disease progression or need for change in therapy within the past 24 months);Only the following special cases are allowed: a. Skin cancer treated within the last 24 months and completely cured; b. Adequately treated lobular carcinoma in situ (LCIS) and ductal CIS; c. History of localized breast cancer and receiving anti-hormonal drugs or history of localized prostate cancer (N0M0) and receiving androgen blockade therapy.
  • History of uncontrolled cardiovascular disease, Included: 1) presence of any of the following in the past 3 months: unstable angina, myocardial infarction, ventricular fibrillation, torsional ventricular tachycardia, cardiac arrest or known congestive New York Heart Association class III-IV heart failure, cerebrovascular accident, or transient ischemic attack. 2) Prolonged QTc intervals confirmed by ECG evaluation during screening(Fridericia; QTc>480 ms). 3) Pulmonary embolism or other venous thromboembolism within the past 2 months.
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  • Pregnant or lactating women;
  • Known infection with human immunodeficiency virus (HIV), unless the subject has been on stable antiretroviral therapy for the past 6 months or longer and has not had an opportunistic infection in the past 6 months and has had a CD4 count >350 in the past 6 months;
  • Evidence of active hepatitis B or C infection (e.g., subjects with hepatitis B who have a history of hepatitis C but have a normal polymerase chain reaction test result for hepatitis C virus and who are positive for antibodies to hepatitis B surface antigen may be enrolled in the study);
  • Have not recovered from toxic effects of previous anticancer therapy (except for toxic effects of no clinical significance, such as alopecia, skin discoloration, neuropathy and hearing impairment).
  • Delayed wound healing, defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or non-healing incisions;
  • Major surgery within 4 weeks prior to day 1 of cycle 1 (TURBT not considered major surgery);
  • Other patients assessed by the investigator to be unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai

Other trials in China

About this study

Official title: A Prospective, Open, Single-center Clinical Study of Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer

This is a prospective, open, single-center clinical study of the anti-HER2(Human epidermal growth factor receptor-2) ADC(antibody-drug conjugate) drug Disitamab Vedotin in combination with BCG(bacillus Calmette-Guerin) therapy in very high-risk NMIBC(Non-muscle invasive bladder cancer) patients with HER2 expression (IHC 1+/2+/3+), which is being conducted in accordance with the Good Clinical Practice for Pharmaceutical Trials (GCP). Approximately 20 subjects will be enrolled in this study to evaluate the efficacy and safety of Disitamab Vedotin (2.0 mg/kg, administered intravenously every three weeks) in combination with BCG therapy.

Read the detailed description

The study will include patients with very high risk NMIBC with HER2 expression (IHC 1+/2+/3+) who refuse to undergo cystectomy or do not meet the requirements for cystectomy. Reasons for unsuitability or refusal of cystectomy will be documented on an electronic case report form (eCRF).

Subjects will receive 6 months of Disitamab Vedotin therapy and at least 1 year of BCG therapy. EFS(Event free survival) and CR(Complete response) rates will be evaluated after treatment by cystoscopy, pathologic histology, urine cytology, laboratory tests, and imaging. Cystoscopy and urine cytology every three months for two years, and radiography every six months. Cystoscopy and urine cytology were done every six months and radiography once a year after two years.

Being tested
Disitamab vedotin, Bacillus Calmette Guerin Vaccine
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Disitamab vedotinDrug

    Also called RC48

    2.0 mg/kg, administered intravenously every three weeks

  • Bacillus Calmette Guerin VaccineDrug

    Also called BCG

    Induction therapy, i.e., intravesical therapy once a week for 6 weeks. maintenance therapy, i.e., one course of maintenance therapy at three, six and twelve months after surgery, each course once a week for 3 weeks.

Study groups in NCT06187506
Study groupRoleWhat they receive
RC48+BCGExperimentalDisitamab Vedotin (2.0 mg/kg, administered intravenously every three weeks); BCG therapy: Induction therapy, i.e., intravesical therapy once a week for 6 weeks. maintenance therapy, i.e., one course of maintenance therapy at three, six and twelve months after surgery, each course once a week for 3 weeks.
Receives: Drug: Disitamab vedotin; Drug: Bacillus Calmette Guerin Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With CR as Assessed by the Investigator according to Cystoscopy and Urine Cytology at Month 3

    CR at the 3-month disease assessment, evaluated by both cystoscopy and cytology.

    Measured: up to 3 months

  2. Event-Free Survival (EFS) rate, as Assessed according to Cystoscopy and Urine Cytology

    Percentage of Participants With Event-Free Survival (EFS), as assessed according to Cystoscopy and Urine Cytology ( patients who are alive and free of persistent/recurrent high-grade NMIBC.)

    Measured: up to 6 months

Secondary outcomes (6)

  1. Percentage of Participants With CR as Assessed by the Investigator according to Cystoscopy and Urine Cytology at Month 6, 12

    CR at the 6, 12-month disease assessment, evaluated by both cystoscopy and cytology.

    Measured: up to 12 months from the date of randomization as assessed by the investigator according to cystoscopic assessment and urine cytology

  2. Duration of CR will be defined for participants with a CR as the time from the first occurrence of a documented complete response to recurrence of high-grade NMIBC or death from any cause.

    Duration of CR will be defined for participants with a CR as the time from the first occurrence of a documented complete response to recurrence of high-grade NMIBC or death from any cause.

    Measured: From first occurence of a documented CR until the time of recurrence of NMIBC or death from any cause, whichever came first, assessed up to 24 months

  3. Percentage of Participants With Event-Free Survival (EFS), as Assessed according to Cystoscopy and Urine Cytology

    EFS rate at 12, 24 months, defined as the proportion of patients who are alive and free of persistent/recurrent high-grade NMIBC.

    Measured: up to 24 months

  4. Progression-Free Survival (PFS), as Assessed according to Cystoscopy and Urine Cytology

    PFS, defined as the time from the first study treatment to the first occurrence of progression to muscle-invasive disease based on cystoscopy and urine cytology or death from any cause.

    Measured: Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

  5. Overall Survival

    defined as the time from first study treatment to death from any cause

    Measured: Time from date of randomization to death from any cause, assessed up to 60 months

  6. Percentage of Participants With Adverse Events

    Percentage of participants with at least one adverse event during the study

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2024
  2. Study start18 Dec 2023
  3. Primary completionSep 2026 (estimated)
  4. Study completionJan 2027 (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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06187506
Sponsor's protocol ID
RC48C066
Status last verified
Jul 2026
First submitted
13 Dec 2023
Last updated
20 Jul 2026
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 Disitamab vedotin and Bacillus Calmette Guerin Vaccine in people with Non-muscle Invasive Bladder Cancer and HER-2 Protein Overexpression, run by Fudan 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 10 inclusion and 13 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 20 Jul 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?

Percentage of Participants With CR as Assessed by the Investigator according to Cystoscopy and Urine Cytology at Month 3 (time frame: up to 3 months). 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?

On the ClinicalTrials.gov record for NCT06187506.

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 20 Jul 2026.

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