Treatment of high-risk non-muscle-invasive bladder cancer with 9MW2821

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

This study is testing a new drug called 9MW2821 to see if it can help people with high-risk non-muscle-invasive bladder cancer who haven't had success with other treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06551233 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a new drug, 9MW2821, in patients suffering from high-risk non-muscle-invasive bladder cancer (NMIBC) who have not responded to previous intravesical therapies. The study aims to provide an alternative treatment option for these patients, potentially reducing tumor recurrence and the need for radical bladder surgery. Participants must have undergone a standard TURBT surgery and have no residual tumors. The trial focuses on improving the quality of life for patients facing this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with high-risk NMIBC who have failed previous intravesical therapies and refuse or are intolerant to radical cystectomy.

Not a fit: Patients with muscle-invasive bladder cancer or those who have not undergone TURBT surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new option for patients with high-risk NMIBC, potentially improving outcomes and quality of life.

How similar studies have performed: While this approach is novel, similar studies targeting high-risk NMIBC have shown promise in improving treatment outcomes.

Eligibility criteria

Inclusion Criteria:

* 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.
* 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).

Exclusion Criteria:

* 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.
* 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.

Where this trial is running

Nanjing, Jiangsu

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Guo Hongqian, PhD

Conditions: Bladder Cancer