Efficacy and Safety of Two Bladder-preserving Treatment Durations With Disitamab Vedotin Plus Toripalimab Combination in Her2-expressing Muscle-invasive Bladder Cancer: A Phase II, Open-Label, Randomized Clinical Trial

NCT07151560 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: WDRY2025-K030
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the efficacy of disitamab vedotin combined with toripalimab as a bladder-preserving treatment combination in patients with HER2 positive locally advanced MIBC, including one year bladder-intact DFS (BI-DFS) and safety.

Conditions

Urology

Keywords

Bladder-preserving; Disitamab Vedotin

Outcome Measures

Primary Outcomes (1)

• one year BI-DFS

  One-year bladder-intact disease-free survival (BI-DFS) rate.

  one year

Study Arms (2)

Cohort 1

EXPERIMENTAL

Cohort 1 will receive RC48-ADC plus toripalimab for 6 cycles

Drug: 6 cycle RC48 and JS001

Cohort 2

EXPERIMENTAL

Cohort 2 will receive RC48-ADC and JS001 for 12 cycles

Drug: 12 cycle RC48 and JS001

Interventions

6 cycle RC48 and JS001 DRUG

Different medication cycles

Cohort 1

12 cycle RC48 and JS001 DRUG

Different medication cycles

Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary agreement to participate in the study and provision of signed and dated informed consent form.
• Male or female, aged ≥ 18 years.
• Life expectancy of ≥ 18 months.
• Pathologically and radiologically confirmed diagnosis of muscle-invasive bladder cancer (MIBC), clinical stage cT2-4aN0M0.
• Ability to provide tumor tissue specimen from the primary site for HER2 testing; HER2 expression of IHC 1+, 2+, or 3+.
• No prior systemic therapy for bladder cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate cardiac, bone marrow, hepatic, and renal function (as per the reference ranges of the investigating center).

You may not qualify if:

• History of malignancies other than urothelial carcinoma, with the following exceptions:Patients who have received potentially curative therapy and have no evidence of the disease for 5 years.Adequately treated basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other in situ carcinomas that have undergone curative resection.
• Conditions affecting drug absorption, distribution, metabolism, or excretion.
• Prior allogeneic stem cell or solid organ transplantation.Prior systemic anti-cancer therapy (including Chinese herbal medications with anti-cancer indications).Less than 4 weeks between the completion of prior therapy and the first dose of study treatment, or presence of persistent adverse events from previous treatments that have not recovered to ≤ Grade 1 per CTCAE (excluding alopecia or pigmentation).
• History or current presence of congenital or acquired immunodeficiency diseases.
• Active or documented history of autoimmune or inflammatory disorders.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Dept. of Urology

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 3, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2030
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share