drugset / Trial / NCT07391670
A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab
RandomizedSequentialOpen-labelTreatment
Summary
The purpose of the study is to determine a subcutaneous (SC: under the skin) durvalumab + recombinant human hyaluronidase (rHu) dose that yields systemic drug exposure similar to intravenous (IV: into the veins) durvalumab administration and to evaluate the pharmacokinetics and safety of SC durvalumab + rHu injection in participants with different types of solid tumours (cancers).
Timeline
- Start
- 2026-03-31
- Primary completion
- 2027-08-30
- Completion
- 2027-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | — | Subcutaneous |
| Background | Tremelimumab | Monoclonal antibody | — | Intravenous |
| Background | rHuPH20 | Protein / enzyme biologic | — | Subcutaneous |