RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects
ConditionNMIBC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRemeGen Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis in accordance with the Chinese Guidelines for the Treatment of Bladder Cancer (2022) high-risk non-muscle invasive bladder cancer (NMIBC) and meeting any of the following ± carcinoma in situ (CIS): 1. stage T1 tumor of any grade; 2. high-grade tumor; 3. multiple and/or recurrent tumors, with recurrent tumors excluding low-grade solitary tumors.
Histopathological satisfaction of uroepithelial carcinoma predominant by histopathology, confirming the absence of muscular infiltration.
Completion of TURBT and resection of all visible lesions within 3 weeks prior to study dosing.
Clinical staging (cTa/T1±CIS, N0, M0) and absence of distant metastases as assessed by imaging (which needs to include at least CTU) within 3 months prior to enrollment.
Disqualifiers
muscle-invasive bladder cancer (T2 and above) and/or with regional lymph nodes and distant metastases
Combined extra-vesical (i.e. urethral, ureteral or renal pelvis) uroepithelial carcinoma.
Received any other antitumor therapy, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc., within 4 weeks prior to study dosing, excluding 1 dose of infusion chemotherapy completed immediately after TURBT.
Have not recovered from an adverse event caused by a previously applied antineoplastic agent to CECAT 5.0 grade 0-1 within 2 weeks prior to the start of study dosing.
Trial design
Treatments tested in this trial
- RC48-ADC in Combination with gemcitabine
Treatment groups
85 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov