Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • RC48-ADC in Combination with gemcitabine

    Drug

    RC48-ADC IV (intravenous) 2.0mg/kg IV, Q2W, 8W; Q4W, 40W Gemcitabine Intravesical 1000mg induction QW,8W; maintenance Q4W,40W

Treatment groups

85 Participants
are divided into 2 treatment groups
Group A: cohort 1Experimental treatment 1 intervention
Group B: cohort 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

12-month Disease Free Survival Rate

Time frame
12 month

Secondary outcomes

1

Complete Response Rate

Time frame
3 month
2

6-month Disease Free Survival Rate

Time frame
6 month
3

18-month Disease Free Survival Rate

Time frame
18 month
4

24-month Disease Free Survival Rate

Time frame
24 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RemeGen Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now