drugset / Trial / NCT05356351
An Open-label, Single-arm, Multicenter Phase II Clinical Study： Evaluating RC48-ADC Combined With Triplizumab in the Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cancer
Phase 2
Not yet recruiting
30 enrolled
Tianjin Medical University Cancer Institute and Hospital
Chongqing University Cancer Hospital · collabFirst Affiliated Hospital Xi'an Jiaotong University · collabHunan Cancer Hospital · collabSouthwest Hospital, China · collabThe First Affiliated Hospital of Air Force Medicial University · collabTongji Hospital · collabXiangya Hospital of Central South University · collab
NaSingle-groupOpen-labelTreatment
Summary
An Open-label, Single-arm, Multicenter Phase II Clinical Study： Evaluating RC48-ADC Combined With Triplizumab in the Neoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cancer.It's arm to evaluate the neoadjuvant treatment of Her2-positive Muscle-invasive Bladder Cancer in patients with objective response rate (ORR),Duration of response (DoR) , progression-free survival (PFS), overall survival (OS), and safety.
Timeline
- Start
- 2022-05-01
- Primary completion
- 2023-07-01
- Completion
- 2027-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Disitamab Vedotin | Monoclonal antibody | 2 mg/kg | — |
| Subject | Triplizumab | Monoclonal antibody | 3 mg/kg | — |