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A Study to Evaluate the Efficacy and Safety of Intravesical Instillation of Disitamab Vedotin Combined With Toripalimab in Patients With HER2-Positive High-Risk Non-Muscle Invasive Bladder Cancer Who Are BCG-Naïve or Have BCG Failure

NCT07783815 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-25

No results posted yet for this study

Summary

This study is an open-label, single-arm investigator-initiated clinical trial, aiming to evaluate the efficacy and safety of vicedetinib bladder instillation combined with teprotumumab in the treatment of patients with HER2-expressing, previously untreated, or BCG-resistant high-risk non-muscle-invasive bladder cancer (NMIBC). The subjects to be included in the study must have undergone standard TURBT within 3 weeks before enrollment, removed all visible lesions, and had a clear pathological diagnosis of NMIBC, with their risk classification according to the "Chinese Bladder Cancer Diagnosis and Treatment Guidelines (2022)" falling into the high-risk group (including extremely high-risk group). All surgical tumor specimens of the included subjects underwent HER2 testing, indicating HER2 expression, defined as immunohistochemistry (IHC) 1+, 2+ or 3+, with FISH verification for amplification if IHC 2+ is present. The subjects were divided into two groups based on whether they had received BCG treatment in the past: one group was high-risk NMIBC patients who had not received BCG treatment, including one of the following situations: ① refused BCG treatment, ② had contraindications to BCG use, ③ BCG was inaccessible; the other group was high-risk NMIBC patients who had no response to BCG, meeting any of the following criteria: ① had persistent/recurrent high-risk NMIBC within 12 months (±1 month) after adequate BCG treatment, ② had high-grade T1 disease during the first assessment after induction BCG treatment. Adequate BCG treatment was defined as completing at least 5 BCG bladder instillations within 2 months, and then at least 2 BCG bladder instillations for 6 consecutive weeks within the next 10 months, meaning at least "5+2" BCG bladder instillations within approximately 12 months. Eligible subjects received vicedetinib bladder instillation combined with teprotumumab treatment; vicedetinib was administered once weekly at 180mg for 8 times. For patients receiving treatment, if there was no occurrence of persistent/recurrent NMIBC, disease progression, or intolerable toxicity, they would receive maintenance bladder instillation with vicedetinib for one year, with the maintenance regimen being: once every 4 weeks for 10 times. Teprotumumab: 240mg per dose, intravenous, once every 3 weeks for 1 year. Patients were required to collect urine samples before the first treatment and after the last treatment. Safety during the study was evaluated according to the NCI-CTCAE V5.0 standard, and the observation indicators included vital signs, physical examination, laboratory tests, electrocardiogram and echocardiogram examinations, adverse events and serious adverse events.

Conditions

Interventions

DRUG

Intravesical Instillation of Disitamab Vedotin Combined with Toripalimab

Eligible subjects will be enrolled and treated with intravesical instillation of disitamab vedotin combined with toripalimab. Disitamab vedotin will be administered at a dose of 180 mg once weekly for 8 consecutive cycles. For treated patients without persistent/recurrent NMIBC, disease progression, or intolerable toxicity, maintenance intravesical instillation of disitamab vedotin will be performed within 1 year. The regimen for maintenance therapy is 180 mg once every 4 weeks for 10 consecutive cycles. Toripalimab will be administered intravenously at a dose of 240 mg once every 3 weeks for 1 consecutive year.

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-09-01
Completion
2030-02-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07783815 on ClinicalTrials.gov