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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Drug: 9MW2821

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Guo Hongqian, PhD; Phone Number: 8613605171690; Email: dr.ghq@nju.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
      • Contact: Guo Hongqian, PhD; Phone Number: 8613605171690; Email: dr.ghq@nju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dose escalation and expansion; Induction period: once a week, 6 times in total. Maintenance period: once per 28 days, 9 times in total. Intravesical therapy	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
• Other Study ID Numbers: IUNU-UC-107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No