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

NCT06551233 | Recruiting Phase 1

• 1 other identifier: IUNU-UC-107
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• DFS rate of 12 months

  Up to 12 months

• DoR of CR

  Up to 20 months

• CR rate of 3/6/12 months

  Up to 12 months

• DFS

  Up to 20 months

• Duration to radical cystectomy

  Up to 20 months

Study Arms (1)

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

Drug: 9MW2821

Interventions

9MW2821 DRUG

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.

dose escalation and expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Guo Hongqian, PhD

CONTACT

8613605171690; dr.ghq@nju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: August 13, 2024
• Study Start: April 22, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

CN (1)