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

Phase 1

Recruiting

• Conditions: Bladder Cancer
• Interventions: Drug: 9MW2821

• Registration Number: NCT06551233
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief 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 enhance the quality of life for patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-22
• Study First Submitted: 2024-04-23
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-11
• Last Update Submitted: 2024-08-11
• Study First Posted: 2024-08-13
• Last Update Posted: 2024-08-13
• Primary Completion: 2024-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dose escalation and expansion	9MW2821	Induction period: once a week, 6 times in total. Maintenance period: once per 28 days, 9 times in total. Intravesical therapy

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	up to 12 months	assess the incidence of AE/SAE
RP2D and MTD	up to 12 months	Determine the recommended phase 2 dose (RP2D) and the maximum tolerated dose (MTD) that may occur.

Secondary Outcome Measures

Name	Time	Method
DFS	Up to 20 months	Disease-free survival
Proportion of radical cystectomy	Up to 20 months	Proportion of radical cystectomy
DFS rate of 12 months	Up to 12 months	Disease-free survival rate of 12 months
DoR of CR	Up to 20 months	Duration of complete response
CR rate of 3/6/12 months	Up to 12 months	Complete response rate of 3/6/12 months
Duration to radical cystectomy	Up to 20 months	Duration to radical cystectomy
Biomarker parameter	Up to 20 months	Expression of Nectin-4

Trial Locations

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China