drugset / Trial / NCT05514158
To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG)
NaSingle-groupOpen-labelTreatment
Summary
This is a single-center, open-label, dose-escalation phase I clinical study.This study aimed to evaluate the safety, tolerability, pharmacokinetics and preliminary clinical efficacy of RC48-ADC combined with RC98 in subjects with advanced gastric cancer.Which will provide a reference basis for dose confirmation in subsequent clinical studies.
Timeline
- Start
- 2022-09-28
- Primary completion
- 2024-05-30
- Completion
- 2024-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Disitamab Vedotin | Monoclonal antibody | 2.5 mg/kg | — |
| Subject | RC98 | Monoclonal antibody | 5 mg/kg | — |
| Subject | RC98 | Monoclonal antibody | 10 mg/kg | — |
| Subject | RC98 | Monoclonal antibody | 15 mg/kg | — |