RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder Cancer
- Registration Number
- NCT05996952
- Lead Sponsor
- West China Hospital
- Brief Summary
This study will evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.
- Detailed Description
This study is a multicenter phase II study, which aims to evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 77
- Be willing and able to provide written informed consent/assent for the trial.
- Life expectancy ≥12 weeks.
- Have a histologically-confirmed diagnosis of high-risk non-muscle-invasive (according to 2023 NCCN guidelines for bladder cancer) transitional cell carcinoma of the bladder. Subjects with tumors of mixed transitional/non-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology.
- Have been treated with adequate BCG therapy and failed (according to 2023 EAU guidelines for NMIBC, for salvage treatment arm).
- Have elected not to undergo, or are considered ineligible for radical cystectomy, as determined by the treating surgeon.
- Have tumor tissues for HER2 IHC evaluation and have a HER2 expression score of HER2 2+ or HER2 3+ reviewed by an independent pathologist at the central laboratory.
- Have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Demonstrate adequate organ function.
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication.
- Male subjects of childbearing potential (Section 5.7.2) must agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy.
- Has muscle-invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic urothelial carcinoma.
- Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/TURBT to starting trial treatment. (Note: A single dose of intravesical treatment given as part of the most recent cystoscopy/TURBT, during the screening period, such as with chemotherapy as per local / regional practices, is acceptable.).
- Allergic to study therapy.
- Has a known additional malignancy that has had progression or has required active treatment in the last five years.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Have diseases that may interfere with the study treatment or severe and uncontrolled concomitant diseases.
- Has had an allogeneic tissue/solid organ transplant.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Salvage RC48-ADC RC48-ADC In this arm, RC48-ADC is evaluated in patients with HER2-positive non-muscle-invasive bladder cancer who failed BCG treatment as an adjuvant treatment. Adjuvant RC48-ADC RC48-ADC In this arm, RC48-ADC is evaluated in patients with HER2-positive high-risk non-muscle-invasive bladder cancer as an adjuvant treatment.
- Primary Outcome Measures
Name Time Method 12-month recurence-free survival rate From treatment initiation to 12 month The probability of patients remaining free of high-risk NMIBC or worse for at least 12 months after first dose of RC48-ADC adjuvant treatment
3-month pathological complete response rate From treatment initiation to 3 month The proportion of patients are negative for urine cytology and cystoscopy at 3 month after first dose of RC48-ADC salvage treatment
Adverse events From patient screening to 30 days after end of cycle 6 The type, incidence, relatedness, and severity of adverse events
- Secondary Outcome Measures
Name Time Method Progression-free survival From time of first dose of RC48-ADC treatment to up to 60 months Time from first dose of RC48-ADC treatment to progression to higher stage or death
6-month recurence-free survival rate From treatment initiation to 6 month The probability of patients remaining free of high-risk NMIBC or worse for at least 6 months after first dose of RC48-ADC adjuvant treatment
Overall survival From time of first dose of RC48-ADC treatment to up to 60 months Time from first dose of RC48-ADC treatment to death from any cause
Quality of life assessed by EQ-5D scale After every cycle of treatment and 30 days after end of cycle 6 Assessed by eEuroQoL EQ-5D scale, higher scores mean better outcomes
Recurrence-free survival From time of first dose of RC48-ADC adjuvant treatment to up to 60 months Time from first dose of RC48-ADC adjuvant treatment to high-risk NMIBC recurrence or worse
Duration of response From time of complete response to up to 60 months Time from complete response to recurrence of any disease
Trial Locations
- Locations (1)
West China Hospital
🇨🇳Chengdu, Sichuan, China