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RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects

NCT05943379 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2023-07-13

No results posted yet for this study

Summary

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

Interventions

DRUG

RC48-ADC in Combination with gemcitabine

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

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-08
Primary Completion
2025-12-01
Completion
2026-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05943379 on ClinicalTrials.gov