drugset / Trial / NCT04042701
DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
Phase 1
Active not recruiting
115 enrolled
Daiichi Sankyo
AstraZeneca · collabMerck Sharp & Dohme LLC · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.
Timeline
- Start
- 2020-02-10
- Primary completion
- 2025-07-21
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 3.2 mg/kg | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/kg | Intravenous |