Actively Recruiting
RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects
Led by RemeGen Co., Ltd. · Updated on 2023-07-13
85
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) who are BCG Naïve or BCG Unresponsive and are considered ineligible for or have refused to undergo radical cystectomy, will receive RC48-ADC in combination with gemcitabine.
CONDITIONS
Official Title
RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary consent to participate and sign informed consent.
- Male or female aged 18 years or older.
- Diagnosed with high-risk non-muscle-invasive bladder cancer meeting specified criteria including stage T1 tumor, high-grade tumor, multiple or recurrent tumors excluding low-grade solitary tumors.
- Histopathology confirming uroepithelial carcinoma without muscle invasion.
- Completed TURBT with resection of all visible lesions within 3 weeks before dosing.
- Clinical staging of cTa/T1±CIS, N0, M0 with no distant metastases based on imaging within 3 months prior.
- For cohort 1: no prior BCG therapy due to refusal, contraindications, or inaccessibility.
- For cohort 2: BCG non-response defined by persistent/recurrent high-risk NMIBC within 12 months of adequate BCG therapy or high-grade T1 disease after induction BCG.
- Deemed unsuitable for or refused radical bladder surgery.
- Tumor tissue HER2 expression of 1+ or higher by immunohistochemistry.
- ECOG performance status 0 to 2.
- Adequate cardiac, bone marrow, liver, and kidney function within 7 days prior to dosing.
- Female participants surgically sterilized, post-menopausal, or agreeing to use approved contraception during treatment and for 6 months after, with negative pregnancy test.
- Male participants agreeing to use approved contraception during treatment and for 6 months after.
- Willing and able to comply with study and follow-up procedures.
You will not qualify if you...
- Muscle-invasive bladder cancer (T2 or above) or with regional lymph node or distant metastases.
- Presence of extra-vesical uroepithelial carcinoma.
- Received other antitumor therapies within 4 weeks prior to dosing, except one infusion chemotherapy dose immediately after TURBT.
- Not recovered from adverse events of previous antitumor agents graded above 1 within 2 weeks prior.
- Major surgery within 4 weeks prior to dosing or planned during study.
- Positive viral tests for hepatitis B, hepatitis C, or HIV with active viral replication.
- Received live vaccines within 4 weeks prior or planned during study (except COVID-19 vaccine).
- Severe heart failure (NYHA grade 3 or higher).
- Recent serious thrombotic or cardiovascular events within 6 months, except asymptomatic lacunar infarction.
- Active infections needing systemic treatment.
- Uncontrolled systemic diseases or serious comorbidities affecting treatment or anesthesia.
- Any other condition or abnormality that poses high risk or affects study results.
- Active autoimmune disease requiring systemic therapy before dosing, except replacement therapies.
- Other cancers within 5 years except certain treated or stable malignancies.
- Previous allogeneic hematopoietic stem cell transplant or organ transplant.
- Known hypersensitivity to study drugs or components.
- Pregnant or breastfeeding women.
- Expected insufficient compliance with study participation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hosptital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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