Non-muscle Invasive Bladder CancerPhase 2NCT05996952
RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder Cancer
A Phase 2 study testing RC48-ADC in people with Non-muscle Invasive Bladder Cancer, run by West China Hospital at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer
- What is being tested?
- RC48-ADC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to provide written informed consent/assent for the trial.
- Life expectancy ≥12 weeks.
- Have a histologically-confirmed diagnosis of high-risk non-muscle-invasive (according to 2023 NCCN guidelines for bladder cancer) transitional cell carcinoma of the bladder. Subjects with tumors of mixed transitional/non-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology.
- Have been treated with adequate BCG therapy and failed (according to 2023 EAU guidelines for NMIBC, for salvage treatment arm).
- Have elected not to undergo, or are considered ineligible for radical cystectomy, as determined by the treating surgeon.
- Have tumor tissues for HER2 IHC evaluation and have a HER2 expression score of HER2 2+ or HER2 3+ reviewed by an independent pathologist at the central laboratory.
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- Have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Demonstrate adequate organ function.
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication.
- Male subjects of childbearing potential (Section 5.7.2) must agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy.
Who cannot join
- Has muscle-invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic urothelial carcinoma.
- Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/TURBT to starting trial treatment. (Note: A single dose of intravesical treatment given as part of the most recent cystoscopy/TURBT, during the screening period, such as with chemotherapy as per local / regional practices, is acceptable.).
- Allergic to study therapy.
- Has a known additional malignancy that has had progression or has required active treatment in the last five years.
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- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Have diseases that may interfere with the study treatment or severe and uncontrolled concomitant diseases.
- Has had an allogeneic tissue/solid organ transplant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Phase II Study of RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive High-risk Non-muscle-invasive Bladder Cancer
This study will evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.
Read the detailed description
This study is a multicenter phase II study, which aims to evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.
- Conditions
- Non-muscle Invasive Bladder Cancer
- Being tested
- RC48-ADC
- 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.
RC48-ADCDrug
Patients are treated with RC48-ADC at 2.0 mg/kg as an intravenous infusion over 30-90 minutes (60 minutes is recommended) once every 2 weeks for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant RC48-ADC | Experimental | In this arm, RC48-ADC is evaluated in patients with HER2-positive high-risk non-muscle-invasive bladder cancer as an adjuvant treatment. Receives: Drug: RC48-ADC |
| Salvage RC48-ADC | Experimental | In this arm, RC48-ADC is evaluated in patients with HER2-positive non-muscle-invasive bladder cancer who failed BCG treatment as an adjuvant treatment. Receives: Drug: RC48-ADC |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month recurence-free survival rate
The probability of patients remaining free of high-risk NMIBC or worse for at least 12 months after first dose of RC48-ADC adjuvant treatment
Measured: From treatment initiation to 12 month
3-month pathological complete response rate
The proportion of patients are negative for urine cytology and cystoscopy at 3 month after first dose of RC48-ADC salvage treatment
Measured: From treatment initiation to 3 month
Adverse events
The type, incidence, relatedness, and severity of adverse events
Measured: From patient screening to 30 days after end of cycle 6
Secondary outcomes (6)
6-month recurence-free survival rate
The probability of patients remaining free of high-risk NMIBC or worse for at least 6 months after first dose of RC48-ADC adjuvant treatment
Measured: From treatment initiation to 6 month
Duration of response
Time from complete response to recurrence of any disease
Measured: From time of complete response to up to 60 months
Recurrence-free survival
Time from first dose of RC48-ADC adjuvant treatment to high-risk NMIBC recurrence or worse
Measured: From time of first dose of RC48-ADC adjuvant treatment to up to 60 months
Progression-free survival
Time from first dose of RC48-ADC treatment to progression to higher stage or death
Measured: From time of first dose of RC48-ADC treatment to up to 60 months
Overall survival
Time from first dose of RC48-ADC treatment to death from any cause
Measured: From time of first dose of RC48-ADC treatment to up to 60 months
Quality of life assessed by EQ-5D scale
Assessed by eEuroQoL EQ-5D scale, higher scores mean better outcomes
Measured: After every cycle of treatment and 30 days after end of cycle 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- More trials run by West China 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RemeGen Co., Ltd.
- Responsible party
- Principal investigator, Hao Zeng, West China Hospital
- Investigators
- Hao Zeng, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996952
- Sponsor's protocol ID
- 2023(24)
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 18 Aug 2023
- 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 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Study of RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive High-risk Non-muscle-invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT05996952
- Acronym / sponsor ID
- 2023(24)
- Conditions
- Non-muscle Invasive Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- RemeGen Co., Ltd.
- Study start
- Aug 2023 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 18 Aug 2023 (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 will evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.
Detailed description
This study is a multicenter phase II study, which aims to evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant RC48-ADC | Experimental | Drug: RC48-ADCIn this arm, RC48-ADC is evaluated in patients with HER2-positive high-risk non-muscle-invasive bladder cancer as an adjuvant treatment. |
| Salvage RC48-ADC | Experimental | Drug: RC48-ADCIn this arm, RC48-ADC is evaluated in patients with HER2-positive non-muscle-invasive bladder cancer who failed BCG treatment as an adjuvant treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be willing and able to provide written informed consent/assent for the trial.
- Life expectancy ≥12 weeks.
- Have a histologically-confirmed diagnosis of high-risk non-muscle-invasive (according to 2023 NCCN guidelines for bladder cancer) transitional cell carcinoma of the bladder. Subjects with tumors of mixed transitional/non-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology.
- Have been treated with adequate BCG therapy and failed (according to 2023 EAU guidelines for NMIBC, for salvage treatment arm).
- Have elected not to undergo, or are considered ineligible for radical cystectomy, as determined by the treating surgeon.
Key exclusion criteria (9 listed)
- Has muscle-invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic urothelial carcinoma.
- Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/TURBT to starting trial treatment. (Note: A single dose of intravesical treatment given as part of the most recent cystoscopy/TURBT, during the screening period, such as with chemotherapy as per local / regional practices, is acceptable.).
- Allergic to study therapy.
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 |
|---|---|---|
| RC48-ADCPatients are treated with RC48-ADC at 2.0 mg/kg as an intravenous infusion over 30-90 minutes (60 minutes is recommended) once every 2 weeks for 12 weeks. | Drug | Adjuvant RC48-ADC, Salvage RC48-ADC |
Primary outcome
12-month recurence-free survival rate
Time frame: From treatment initiation to 12 month
The probability of patients remaining free of high-risk NMIBC or worse for at least 12 months after first dose of RC48-ADC adjuvant treatment
3-month pathological complete response rate
Time frame: From treatment initiation to 3 month
The proportion of patients are negative for urine cytology and cystoscopy at 3 month after first dose of RC48-ADC salvage treatment
Adverse events
Time frame: From patient screening to 30 days after end of cycle 6
The type, incidence, relatedness, and severity of adverse events
6 secondary outcomes
6-month recurence-free survival rate
Time frame: From treatment initiation to 6 month
Duration of response
Time frame: From time of complete response to up to 60 months
Recurrence-free survival
Time frame: From time of first dose of RC48-ADC adjuvant treatment to up to 60 months
Progression-free survival
Time frame: From time of first dose of RC48-ADC treatment to up to 60 months
Overall survival
Time frame: From time of first dose of RC48-ADC treatment to up to 60 months
Quality of life assessed by EQ-5D scale
Time frame: After every cycle of treatment and 30 days after end of cycle 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- 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.
Hao Zeng principal investigator
West China Hospital
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 RC48-ADC in people with Non-muscle Invasive Bladder Cancer, run by West China Hospital 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 9 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: status not confirmed, as of the sponsor's last update on 18 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Zeng (8602885422114, kucaizeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month recurence-free survival rate (time frame: From treatment initiation to 12 month). The study lists 3 primary outcomes in all. 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 18 Aug 2023.