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A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab
Sponsor: AstraZeneca
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).
Official title: A Phase I, Multicentre, Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab in Adult Participants With Solid Tumours
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-03-31
Completion Date
2027-08-30
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
SC durvalumab + rHu
Durvalumab + rHu will be administered subcutaneously.
IV durvalumab
Durvalumab will be administered intravenously.
Tremelimumab
Tremelimumab will be administered to participants with unresectable HCC as an IV infusion.
Locations (19)
Research Site
Fitzroy, Australia
Research Site
St Albans, Australia
Research Site
Woolloongabba, Australia
Research Site
Batumi, Georgia
Research Site
Tbilisi, Georgia
Research Site
Tbilisi, Georgia
Research Site
Brzozów, Poland
Research Site
Koszalin, Poland
Research Site
Lublin, Poland
Research Site
Olsztyn, Poland
Research Site
Przemyśl, Poland
Research Site
Seongnam-si, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taoyuan District, Taiwan