RecruitingPhase 2NCT05957757

RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression

RC48 Combined With Tislelizumab for Bladder Sparing Treatment in High-risk Non-muscular Invasive Bladder Cancer (NMIBC) With BCG Treatment Failure and HER2 Expression

Sponsor

RenJi Hospital

Enrollment

20 participants

Start Date

Aug 5, 2023

Study Type

INTERVENTIONAL

Conditions

HER2 Non Muscle Invasive Bladder Cancer

Summary

This is a prospective, open, single-center clinical study of anti-HER2-ADC combined with PD-1 monoclonal antibody for bladder sparing treatment in non-muscular invasive bladder cancer (NMIBC) patients with HER2-expressing. The study was conducted in accordance with the Good Clinical Practice (GCP). Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (RC48 2.0 mg/kg intravenously administered every two weeks) combined with Tislelizumab (Tislelizumab 200 mg intravenously administered every three weeks). Subjects undergo Transurethral resection of bladder tumor (TURBT), imaging diagnosis and pre-treatment biological samples of blood, urine and biopsy tissue. The study will include high-risk NMIBC patients who express HER2, fail after BCG treatment, but refuse to undergo cystectomy or do not meet the requirements for cystectomy. Subjects will receive RC48 and Tislelizumab for two years. BI-DFS were evaluated by cystoscopy, histopathologic examination, laboratory examination, and imaging examination after treatment, and tumor efficacy was evaluated when clinical studies reached the number of subjects specified in the protocol for efficacy evaluation.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of RC48 (an antibody-drug designed to target HER2, a protein overexpressed in some cancers) and tislelizumab (an immune checkpoint drug) as a bladder-preserving treatment for non-muscle invasive bladder cancer that stopped responding to the standard BCG treatment. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of high-risk non-muscle invasive bladder cancer - Your cancer came back or didn't respond to BCG (a standard bladder cancer treatment) - Your tumor expresses HER2 protein - You have refused or are not suitable for complete bladder removal surgery - Your overall health is good and organ function meets required levels **You may NOT be eligible if...** - Your cancer has invaded the muscle layer of the bladder (T2 or higher) - You have previously received anti-PD-1/PD-L1 or anti-HER2 therapy - You have significant heart disease, active hepatitis, or HIV - You are pregnant or breastfeeding - You had major surgery within 4 weeks prior Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRC48

RC48 was scheduled to be administered at a dose of 2.0mg/kg every 2 weeks, with the first dose on day 1 of the first cycle. The drug is diluted with normal saline and administered by intravenous drip for one hour.

DRUGTislelizumab

Tislelizumab was administered at a dose of 200 mg every 3 weeks, with the first dose on day 1 of the first 21-day cycle. The drug is diluted with normal saline and administered by intravenous drip for one hour.