HER2-expressing High-risk or Very High-risk NMIBC Without Visible Foci of Disease After TURBTPhase 2NCT07100184
RC48 in Combination With Radiotherapy for HER2-Expressing NMIBC Patients
A Phase 2 study testing Disitamab Vedotin combined with Radiotherapy in people with HER2-expressing High-risk or Very High-risk NMIBC Without Visible Foci of Disease After TURBT, run by Peking University First Hospital.
Trial summary
This study is an open, single-arm, single-center exploratory clinical study to explore the efficacy and safety of Disitamab Vedotin (RC-48) in combination with radiotherapy for the treatment of patients with HER2-expressing high-risk or very high-risk non-muscle invasive bladder cancer (NMIBC) without visible foci of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-expressing High-risk or Very High-risk NMIBC Without Visible Foci of Disease After TURBT
- What is being tested?
- Disitamab Vedotin combined with Radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Dec 2028
- 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
- voluntarily agree to participate in the study and sign an informed consent form;
- male or female, age ≥18 years;
- disease fulfillment:
- the patient's disease status was determined by at least two associate or chief physicians to be free of visible lesions to the naked eye after transurethral bladder tumor electrodessication;
- A definitive postoperative pathologic diagnosis of non-muscle invasive bladder cancer with >50% of its major tissue component being uroepithelial carcinoma (migratory cell carcinoma);
- Completion of TURBT within 4 weeks prior to study administration and completion of immediate chemotherapy infusion (chemotherapy agent is mitomycin);
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- Absence of focal lymph node metastasis as well as distant metastasis confirmed by imaging (including but not limited to thoracoabdominopelvic CT/MR or PET/CT) within 6 weeks prior to enrollment, i.e., N0M0;
- Subject's NMIBC risk grouping is consistent with a high or very high risk group:
- patient refuses or is unfit to receive BCG infusion; BCG intolerance or progression of BCG therapy;
- the subject meets 2+ or 3+ HER2 expression by immunohistochemistry (IHC) of tumor tissue obtained by TURBT within 4 weeks;
- a score of 0-1 on the ECOG Physical Status Scale;
- adequate cardiac, bone marrow, hepatic, and renal functions
Who cannot join
- combined extravesical (i.e., urethral, ureteral, or renal pelvic) uroepithelial cancer;
- have received any other antineoplastic therapy, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc., within 4 weeks prior to study dosing, excluding 1 instillation of chemotherapy completed immediately after TURBT;
- has not recovered to CECAT 5.0 grade 0-1 from an adverse event caused by a previously applied antineoplastic agent within 2 weeks prior to initiation of study drug administration;
- who have had major surgery within 4 weeks prior to the start of study dosing or are scheduled to have major surgery during the study period;
- Serum virology: a) Positive HBsAg with a positive HBVDNA copy number. b) Positive HCVAb with a positive HBVDNA copy number. c) Positive HBsAg with a positive HBVDNA copy number. d) Positive HBsAg with a positive HBV DNA copy number;
- have received a live vaccine within 4 weeks prior to the start of study drug administration or plan to receive any vaccine during the study period;
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- heart failure classified by the New York Heart Association (NYHA) as Grade 3 or higher;
- a serious arterial/venous thrombotic event or cardiovascular accident such as deep vein thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc., except for lacunar cerebral infarcts, which are asymptomatic and do not require clinical intervention, within the 6 months prior to study dosing;
- the presence of an active infection requiring systemic therapy, such as active tuberculosis;
- the presence of systemic diseases or serious comorbidities that, in the judgment of the investigator, are active and not under stable control, including diabetes mellitus, hypertension, cirrhosis of the liver, interstitial pneumonitis, obstructive lung disease, and that would allow subjects to develop complications as a result of receiving intravesical therapy and/or general anesthesia
- the presence of any other disease, metabolic abnormality, physical examination abnormality, or laboratory test abnormality that, in the judgment of the investigator, gives reason to suspect that the patient has a disease or condition that is unsuitable for the use of the study medication, or that will interfere with the interpretation of the results of the study, or that places the patient at a high risk of developing the study;
- active autoimmune disease requiring systemic therapy (e.g., use of immunomodulatory agents, corticosteroids, or immunosuppressive agents) was present prior to the initiation of study drug administration, allowing for relevant replacement therapy (e.g., replacement therapy with thyroxine for adrenal or pituitary insufficiency, or physiologic corticosteroids);
- other malignancies within 5 years prior to the start of study drug administration.
- a history of previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
- known hypersensitivity to recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent drugs and their components;
- pregnant or lactating women;
- estimated to have insufficient patient compliance for participation in this clinical study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for Patients With HER2-Expressing High-Risk or Very High-Risk Non-Muscle Invasive Bladder Cancer
This study is an open, single-arm, single-center exploratory clinical study to explore the efficacy and safety of Disitamab Vedotin (RC-48) in combination with radiotherapy for the treatment of patients with HER2-expressing high-risk or very high-risk non-muscle invasive bladder cancer (NMIBC) without visible foci of disease after transurethral resection of bladder tumor (TURBT). The study plans to enroll 30 patients with high or very high risk HER2-expression NMIBC without visible lesions after TURBT. The study includes a screening period, a treatment period, and a survival follow-up period. This is a single-center study conducted at the Peking University First Hospital, and the PI is Prof. CuiJian Zhang.
- Conditions
- HER2-expressing High-risk or Very High-risk NMIBC Without Visible Foci of Disease After TURBT
- Being tested
- Disitamab Vedotin combined with Radiotherapy
- Keywords
- non-muscle invasive bladder cancer, NMIBC, HER-2, Disitamab Vedotin, Radiotherapy
- 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 Vedotin combined with RadiotherapyDrug
Disitamab Vedotin (RC-48) injection 2mg/kg, Q2w for 4 circles before radiotherapy and 2mg/kg, Q3w for 8 circles after radiotherapy; Radiotherapy (Whole bladder dose: 25 Gy in 5 doses, QD)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | patients with HER2-expressing high-risk or very high-risk non-muscle invasive bladder cancer (NMIBC) without visible foci of disease after transurethral resection of bladder tumor (TURBT) Receives: Drug: Disitamab Vedotin combined with Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month disease-free survival (DFS) rate
Proportion of patients with complete remission confirmed by urine cytology, thoracic-abdominal-pelvic MR, and cystoscopy as a percentage of all patients receiving the full course of medication at 12 months after treatment;
Measured: 12 months after treatment
Secondary outcomes (4)
24-month disease-free survival (DFS) rate
Proportion of patients with complete remission confirmed by urine cytology, thoracic-abdominal-pelvic MR, and cystoscopy as a percentage of all patients receiving the full course of medication at 24 months after treatment;
Measured: 24 months after treatment
36-month disease-free survival (DFS) rate
Proportion of patients with complete remission confirmed by urine cytology, thoracic-abdominal-pelvic MR, and cystoscopy as a percentage of all patients receiving the full course of medication at 36 months after treatment;
Measured: 36 months after treatment
disease-free survival (DFS)
Measured: From the date of initiation of RC48-based therapy until the date of first documented disease recurrence, progression to muscle-invasive bladder cancer, radical cystectomy, or death from any cause, whichever occurs first, assessed up to 60 months.
overall survival (OS)
Measured: From the date of initiation of RC48-based therapy until the date of death from any cause, assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-expressing High-risk or Very High-risk NMIBC Without Visible Foci of Disease After TURBTStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RemeGen Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100184
- Sponsor's protocol ID
- RC48-RT-01
- Status last verified
- Jun 2025
- First submitted
- 21 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for Patients With HER2-Expressing High-Risk or Very High-Risk Non-Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07100184
- Acronym / sponsor ID
- RC48-RT-01
- Conditions
- HER2-expressing High-risk or Very High-risk NMIBC Without Visible Foci of Disease After TURBT
- Keywords
- non-muscle invasive bladder cancer, NMIBC, HER-2, Disitamab Vedotin, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- RemeGen Co., Ltd.
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Aug 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 study is an open, single-arm, single-center exploratory clinical study to explore the efficacy and safety of Disitamab Vedotin (RC-48) in combination with radiotherapy for the treatment of patients with HER2-expressing high-risk or very high-risk non-muscle invasive bladder cancer (NMIBC) without visible foci of disease after transurethral resection of bladder tumor (TURBT). The study plans to enroll 30 patients with high or very high risk HER2-expression NMIBC without visible lesions after TURBT. The study includes a screening period, a treatment period, and a survival follow-up period. This is a single-center study conducted at the Peking University First Hospital, and the PI is Prof. CuiJian Zhang.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Disitamab Vedotin combined with Radiotherapypatients with HER2-expressing high-risk or very high-risk non-muscle invasive bladder cancer (NMIBC) without visible foci of disease after transurethral resection of bladder tumor (TURBT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- voluntarily agree to participate in the study and sign an informed consent form;
- male or female, age ≥18 years;
- disease fulfillment:
- patient refuses or is unfit to receive BCG infusion; BCG intolerance or progression of BCG therapy;
- the subject meets 2+ or 3+ HER2 expression by immunohistochemistry (IHC) of tumor tissue obtained by TURBT within 4 weeks;
Key exclusion criteria (17 listed)
- combined extravesical (i.e., urethral, ureteral, or renal pelvic) uroepithelial cancer;
- have received any other antineoplastic therapy, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc., within 4 weeks prior to study dosing, excluding 1 instillation of chemotherapy completed immediately after TURBT;
- has not recovered to CECAT 5.0 grade 0-1 from an adverse event caused by a previously applied antineoplastic agent within 2 weeks prior to initiation of study drug administration;
- who have had major surgery within 4 weeks prior to the start of study dosing or are scheduled to have major surgery during the study period;
- Serum virology: a) Positive HBsAg with a positive HBVDNA copy number. b) Positive HCVAb with a positive HBVDNA copy number. c) Positive HBsAg with a positive HBVDNA copy number. d) Positive HBsAg with a positive HBV DNA copy number;
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 combined with RadiotherapyDisitamab Vedotin (RC-48) injection 2mg/kg, Q2w for 4 circles before radiotherapy and 2mg/kg, Q3w for 8 circles after radiotherapy; Radiotherapy (Whole bladder dose: 25 Gy in 5 doses, QD) | Drug | Experimental Arm |
Primary outcome
12-month disease-free survival (DFS) rate
Time frame: 12 months after treatment
Proportion of patients with complete remission confirmed by urine cytology, thoracic-abdominal-pelvic MR, and cystoscopy as a percentage of all patients receiving the full course of medication at 12 months after treatment;
4 secondary outcomes
24-month disease-free survival (DFS) rate
Time frame: 24 months after treatment
36-month disease-free survival (DFS) rate
Time frame: 36 months after treatment
disease-free survival (DFS)
Time frame: From the date of initiation of RC48-based therapy until the date of first documented disease recurrence, progression to muscle-invasive bladder cancer, radical cystectomy, or death from any cause, whichever occurs first, assessed up to 60 months.
overall survival (OS)
Time frame: From the date of initiation of RC48-based therapy until the date of death from any cause, assessed up to 100 months.
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 3 Aug 2025.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Disitamab Vedotin combined with Radiotherapy in people with HER2-expressing High-risk or Very High-risk NMIBC Without Visible Foci of Disease After TURBT, run by Peking University First Hospital.
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 12 inclusion and 17 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: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Cuijian Zhang, MD. (+86 010-83572418, surgeon_zhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month disease-free survival (DFS) rate (time frame: 12 months after treatment). 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 3 Aug 2025.