NMIBC Clinical Trial
Official title:
An Open-label, Single Arm, Single Center Phase 2 Study of RC48-ADC (IV) in Combination With Gemcitabine(Intravesical) in High Risk NMIBC Subjects (BCG Naïve or BCG Unresponsive) That Expresses HER2 (IHC 1+ and Greater)
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.
The study will be comprised of 2 cohorts. The cohort 1 is BCG Naïve and cohor 2 is BCG Unresponsive. All participants will receive RC48-ADC(IV) in combination with gemcitabine(intravesical). Treatment on the study will occur during the induction and maintenance phases, and participants will enter a follow-up period after completion of the maintenance phase. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03914794 -
A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors
|
Phase 2 | |
| Recruiting |
NCT06126796 -
Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
|
||
| Recruiting |
NCT05375903 -
A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
|
Phase 1 | |
| Recruiting |
NCT06181266 -
A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer
|
Phase 1 | |
| Recruiting |
NCT05014139 -
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
|
Phase 1 |