Bladder CancerPhase 1NCT06551233
Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC)
A Phase 1 study testing 9MW2821 in people with Bladder Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Assess the safety and efficacy of 9MW2821 in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who have previously failed to intravesical therapy. Provide a new treatment option for patients with NMIBC recurrence, reduce the risk of tumor recurrence, decrease the rate of radical bladder surgery, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- 9MW2821
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2024to 31 Dec 2025
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years old before signing the informed consent.
- Subjects must have previously failed to at least one kind of intravesical therapy, including but not limited to BCG, gemcitabine, etc.
- Subjects refuse or are intolerant to BCG therapy.
- Subjects must have completed a standard TURBT surgery within 6 weeks before the first dose of the study drug and have no evidence of residual tumors in the surgical field.
- Tumor tissue samples from TURBT must be provided (≥5 slides), along with relevant pathological reports.
- Histological and pathological diagnosis of urothelial carcinoma (with a major component >50%) , with the confirmation of no-muscle invasion.
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- Subjects must be categorized as high-risk NMIBC
- Subjects refuse or are intolerant to radical cystectomy.
- Clinical non-metastatic bladder cancer (N0, M0) determined by CT scan.
- Adequate function of heart, bone marrow, liver, and kidney.
- ECOG 0-1
- Subjects must be willing to take highly effective contraception during the study and 180 days after the last dose of 9MW2821 (a negative serum pregnancy test result within ≤7 days before enrollment for the female).
Who cannot join
- History of muscle invasive or metastatic bladder cancer.
- History of other malignancies within 3 years.
- Other systemic anti-cancer therapies within 3 weeks before the first dose of the study drug.
- Surgery (such as TURBT) or radiotherapy for bladder lesions within 2 weeks before the first dose.
- Hypersensitivity reactions to certain components of 9MW2821 or similar drugs.
- Persistence of adverse reactions caused by prior anti-tumor therapy before the first dose, does not recover to grade 1 and below, according to NCI-CTCAE v5.0.
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- Active systemic infections that require treatments within 7 days before the first dose.
- Severe cardiovascular diseases within 6 months before the first dose.
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- History of autoimmune diseases.
- Serum virology tests: positive results for HBsAg or HBcAb, with positive HBV-DNA copies (≥500IU/mL); positive HCV-Ab results, with positive HCV-RNA results; positive HIV-Ab results.
- Prior treatment with drugs targeted Nectin-4 or MMAE-conjugated ADC.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu
Guo Hongqian, PhD, 8613605171690, dr.ghq@nju.edu.cn
About this study
Official title: A Clinical Study on the Safety and Efficacy of 9MW2821 in Patients With High-risk Non-muscle-invasive Bladder Cancer (NMIBC) That Have Previously Failed to Intravesical Therapy
Assess the safety and efficacy of 9MW2821 in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who have previously failed to intravesical therapy. Provide a new treatment option for patients with NMIBC recurrence, reduce the risk of tumor recurrence, decrease the rate of radical bladder surgery, and enhance the quality of life for patients.
- Conditions
- Bladder Cancer
- Being tested
- 9MW2821
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9MW2821Drug
Patients will be evaluated from low dose to high dose through intravesical therapy and then select the suitable doses to expand according to study data.
| Study group | Role | What they receive |
|---|---|---|
| dose escalation and expansion | Experimental | Induction period: once a week, 6 times in total. Maintenance period: once per 28 days, 9 times in total. Intravesical therapy Receives: Drug: 9MW2821 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
assess the incidence of AE/SAE
Measured: up to 12 months
RP2D and MTD
Determine the recommended phase 2 dose (RP2D) and the maximum tolerated dose (MTD) that may occur.
Measured: up to 12 months
Secondary outcomes (7)
DFS rate of 12 months
Disease-free survival rate of 12 months
Measured: Up to 12 months
DoR of CR
Duration of complete response
Measured: Up to 20 months
CR rate of 3/6/12 months
Complete response rate of 3/6/12 months
Measured: Up to 12 months
DFS
Disease-free survival
Measured: Up to 20 months
Duration to radical cystectomy
Duration to radical cystectomy
Measured: Up to 20 months
Proportion of radical cystectomy
Proportion of radical cystectomy
Measured: Up to 20 months
Biomarker parameter
Expression of Nectin-4
Measured: Up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start22 Apr 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551233
- Sponsor's protocol ID
- IUNU-UC-107
- Status last verified
- Aug 2024
- First submitted
- 23 Apr 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Efficacy of 9MW2821 in Patients With High-risk Non-muscle-invasive Bladder Cancer (NMIBC) That Have Previously Failed to Intravesical Therapy
- ClinicalTrials.gov ID
- NCT06551233
- Acronym / sponsor ID
- IUNU-UC-107
- Conditions
- Bladder Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Aug 2024 (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.
Assess the safety and efficacy of 9MW2821 in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who have previously failed to intravesical therapy. Provide a new treatment option for patients with NMIBC recurrence, reduce the risk of tumor recurrence, decrease the rate of radical bladder surgery, and enhance the quality of life for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dose escalation and expansion | Experimental | Drug: 9MW2821Induction period: once a week, 6 times in total. Maintenance period: once per 28 days, 9 times in total. Intravesical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age≥18 years old before signing the informed consent.
- Subjects must have previously failed to at least one kind of intravesical therapy, including but not limited to BCG, gemcitabine, etc.
- Subjects refuse or are intolerant to BCG therapy.
- Subjects must have completed a standard TURBT surgery within 6 weeks before the first dose of the study drug and have no evidence of residual tumors in the surgical field.
- Tumor tissue samples from TURBT must be provided (≥5 slides), along with relevant pathological reports.
Key exclusion criteria (12 listed)
- History of muscle invasive or metastatic bladder cancer.
- History of other malignancies within 3 years.
- Other systemic anti-cancer therapies within 3 weeks before the first dose of the study drug.
- Surgery (such as TURBT) or radiotherapy for bladder lesions within 2 weeks before the first dose.
- Hypersensitivity reactions to certain components of 9MW2821 or similar drugs.
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 |
|---|---|---|
| 9MW2821Patients will be evaluated from low dose to high dose through intravesical therapy and then select the suitable doses to expand according to study data. | Drug | dose escalation and expansion |
Primary outcome
Safety and tolerability
Time frame: up to 12 months
assess the incidence of AE/SAE
RP2D and MTD
Time frame: up to 12 months
Determine the recommended phase 2 dose (RP2D) and the maximum tolerated dose (MTD) that may occur.
7 secondary outcomes
DFS rate of 12 months
Time frame: Up to 12 months
DoR of CR
Time frame: Up to 20 months
CR rate of 3/6/12 months
Time frame: Up to 12 months
DFS
Time frame: Up to 20 months
Duration to radical cystectomy
Time frame: Up to 20 months
Proportion of radical cystectomy
Time frame: Up to 20 months
Biomarker parameter
Time frame: Up to 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 9MW2821 in people with Bladder Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 12 inclusion and 12 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 13 Aug 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Guo Hongqian, PhD (8613605171690, dr.ghq@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: up to 12 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?
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 13 Aug 2024.