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Recruiting NCT06551233

Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC)

Phase I Interventional Bladder Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 9MW2821.
Who it may be relevant to
Registry conditions: Bladder Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug 9MW2821
    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.

Primary outcome measures

  • Safety and tolerability [Time frame: up to 12 months]
  • RP2D and MTD [Time frame: up to 12 months]
Secondary outcome measures (7)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing

Identifiers

NCT: NCT06551233 · IUNU-UC-107

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗