Actively Recruiting
RC48-ADC Intravenous With Gemcitabine Intravesical in High Risk NMIBC Patients Expressing HER2 (BCG Naïve or Unresponsive) Phase 2 Open-label Study
Led by RemeGen Co., Ltd. · Updated on 2023-07-13
85
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who either have not received BCG therapy or have not responded to it and are not suitable for or have declined radical bladder removal surgery. This study focuses on patients whose tumors express HER2 at levels of 1+ or greater. The purpose is to assess the combination of RC48-ADC and gemcitabine in these specific patient groups to better understand its effects and disease control. Participants will be divided into two groups: those who are BCG Naïve and those who are BCG Unresponsive. All participants will receive intravenous RC48-ADC at 2.0 mg/kg every two weeks for eight weeks, then every four weeks for up to forty weeks. Alongside this, gemcitabine will be administered intravesically once weekly for eight weeks during induction and then every four weeks for up to forty weeks during maintenance. After completing treatment phases, participants will enter a follow-up period for continued monitoring. During the study, participants will undergo regular assessments including imaging to confirm cancer status and safety monitoring. Researchers will measure outcomes such as 12-month disease-free survival, recurrence-free survival up to 24 months, and overall survival up to five years. Safety and disease progression will be carefully tracked throughout treatment and follow-up. Participants must comply with study procedures and follow-up visits, which will include physical exams, laboratory tests, and evaluations of heart and organ function.
CONDITIONS
Brief 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, age 18 years or older.
- Diagnosed with high-risk non-muscle-invasive bladder cancer according to Chinese guidelines, including stage T1 tumor, high-grade tumor, or multiple/recurrent tumors.
- Histopathology confirming uroepithelial carcinoma without muscle infiltration.
- Completion of TURBT and resection of all visible lesions within 3 weeks prior to study dosing.
- Clinical staging of cTa/T1 with or without carcinoma in situ, no lymph node or distant metastases confirmed by imaging within 3 months prior.
- Cohort 1: BCG Naïve patients who have not received prior BCG therapy due to refusal, contraindications, or inaccessibility.
- Cohort 2: BCG Unresponsive patients meeting criteria for persistent/recurrent high-risk NMIBC within 12 months after adequate BCG therapy.
- Assessed as unsuitable for or have refused radical bladder cancer surgery.
- Tumor tissue must show HER2 expression of 1+ or higher by immunohistochemistry.
- ECOG physical status score of 0-2.
- Adequate cardiac, bone marrow, liver, and renal function within 7 days prior to dosing.
- Women must be surgically sterilized, post-menopausal, or agree to contraception during treatment and for 6 months after; negative pregnancy test required.
- Men must agree to contraception during treatment and for 6 months after.
- Willing and able to comply with the trial and follow-up procedures.
You will not qualify if you...
- Muscle-invasive bladder cancer (T2 or higher) or lymph node/distant metastases.
- Presence of extra-vesical uroepithelial carcinoma.
- Received other antitumor therapies within 4 weeks prior to dosing, except one infusion chemotherapy after TURBT.
- Unrecovered adverse events from previous antineoplastic agents (grade above 1) within 2 weeks prior to dosing.
- Major surgery within 4 weeks prior to dosing or planned during the trial.
- Positive for active hepatitis B, hepatitis C, or HIV infection.
- Received live vaccine within 4 weeks prior to dosing or planned vaccination during study (except COVID-19 vaccine).
- Heart failure classified as NYHA grade 3 or higher.
- Serious thrombotic or cardiovascular events within 6 months prior to dosing, except asymptomatic lacunar infarction.
- Active infection requiring systemic treatment.
- Uncontrolled systemic diseases or serious comorbidities.
- Other diseases or lab abnormalities that may affect study safety or results.
- Active autoimmune disease requiring systemic therapy prior to dosing.
- Other malignancies within 5 years prior to dosing with certain exceptions.
- Previous allogeneic hematopoietic stem cell transplant or organ transplantation.
- Known hypersensitivity to study drugs or components.
- Pregnant or breastfeeding women.
- Estimated insufficient compliance for study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Induction phase: 8 weeks; Maintenance phase: 40 weeks
Participants receive intravenous RC48-ADC and intravesical gemcitabine during induction and maintenance phases.
Intravenous treatment every 2 weeks during induction and every 4 weeks during maintenance; intravesical treatment weekly during induction and every 4 weeks during maintenance
Duration - Up to approximately 24 months or longer as per study assessments
Participants are monitored after completion of maintenance treatment to assess ongoing health and disease status.
Visits scheduled according to follow-up assessments up to 24 months
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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