Actively Recruiting
Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer
Led by Fudan University · Updated on 2024-07-12
20
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, open, single-center clinical study of the anti-HER2(Human epidermal growth factor receptor-2) ADC(antibody-drug conjugate) drug Disitamab Vedotin in combination with BCG(bacillus Calmette-Guerin) therapy in very high-risk NMIBC(Non-muscle invasive bladder cancer) patients with HER2 expression (IHC 1+/2+/3+), which is being conducted in accordance with the Good Clinical Practice for Pharmaceutical Trials (GCP). Approximately 20 subjects will be enrolled in this study to evaluate the efficacy and safety of Disitamab Vedotin (2.0 mg/kg, administered intravenously every three weeks) in combination with BCG therapy.
CONDITIONS
Official Title
Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed non-muscle-invasive urothelial cell carcinoma of the bladder
- HER2 expression (IHC 1+, 2+, or 3+) confirmed by pathology
- Very high risk NMIBC with at least one of: multiple or large (>3 cm) T1 (high grade) tumors, T1 high grade tumor with concurrent carcinoma in situ, T1 high grade with CIS in prostatic urethra, or micropapillary variant
- Received first dose of medication within 12 weeks of first TURBT
- Refusal or unsuitability for radical cystectomy
- ECOG performance status of 0 or 1
- Adequate blood and organ function, including creatinine clearance ≥30 mL/min
- Signed informed consent form
- Negative pregnancy test for females of childbearing potential within 7 days prior to first dose
You will not qualify if you...
- Evidence of locally advanced, metastatic, muscle-invasive, or extravesical bladder cancer
- Upper urinary tract urothelial carcinoma except if no recurrence for 2 years after previous radical treatment
- Presence of small cell component, simple adenocarcinoma, simple squamous cell carcinoma, or simple squamous CIS
- Prior anti-HER2 therapy
- Active malignancy outside the study disease unless fully treated skin cancer, lobular or ductal carcinoma in situ, or localized breast or prostate cancer under specific treatments
- Uncontrolled cardiovascular disease or recent serious cardiac events
- Prolonged QTc interval on ECG
- Recent pulmonary embolism or venous thromboembolism
- Pregnant or breastfeeding women
- Known HIV infection unless stable on therapy with no recent infections and adequate CD4 count
- Active hepatitis B or C infection
- Not recovered from prior cancer therapy toxicities except minor ones
- Delayed wound healing or recent major surgery except TURBT
- Other conditions making participation unsuitable as assessed by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
Y
Yijun Shen, Doctor
CONTACT
D
Dingwei Ye, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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