drugset / Trial / NCT05034887
Phase 2 Study of Trastuzumab Deruxtecan in the Neoadjuvant Treatment, or Trastuzumab Deruxtecan Plus Capecitabine Plus Durvalumab(MEDI4736) in the Preoperative and Postoperative Adjuvant Treatment for Patients With HER2 Positive Gastric and Gastroesophageal Junction Adenocarcinoma
Phase 2
Active not recruiting
64 enrolled
National Cancer Center Hospital East
Daiichi Sankyo · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study is an open-label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of neoadjuvant chemotherapy with T-DXd monotherapy in patients with HER2-positive gastric cancer. In the combination cohort, the efficacy and safety of neoadjuvant chemotherapy combined with T-DXd, capecitabine, and durvalumab are evaluated.
Timeline
- Start
- 2022-01-31
- Primary completion
- 2028-03-31
- Completion
- 2029-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 750 mg/m2 | Oral |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/kg | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 6.4 mg/kg | Intravenous |