A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab - IMFINZI-subQ
Study identifier:D907HC00001
ClinicalTrials.gov identifier:NCT07391670
EudraCT identifier:N/A
CTIS identifier:2025-521639-34-00
Will Be Recruiting
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
Medical condition
Solid tumours
Phase
Phase 1
Healthy volunteers
No
Study drug
SC durvalumab + rHu, IV durvalumab, Tremelimumab
Sex
All
Estimated Enrollment
40
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 31 Mar 2026
Estimated Primary Completion Date: 30 Aug 2027
Estimated Study Completion Date: 30 Aug 2027
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2026 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Part 1: SC Durvalumab DL1 Participants will receive DL1 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals. | Drug: SC durvalumab + rHu Durvalumab + rHu will be administered subcutaneously. Drug: IV durvalumab Durvalumab will be administered intravenously. Other Name: MEDI4736 Drug: Tremelimumab Tremelimumab will be administered to participants with unresectable HCC as an IV infusion. |
| Experimental: Part 1: SC Durvalumab DL2 Participants will receive DL2 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals. | Drug: SC durvalumab + rHu Durvalumab + rHu will be administered subcutaneously. Drug: IV durvalumab Durvalumab will be administered intravenously. Other Name: MEDI4736 Drug: Tremelimumab Tremelimumab will be administered to participants with unresectable HCC as an IV infusion. |
| Experimental: Part 2: Expansion Cohort, SC Durvalumab Dose Level X Participants will receive dose level X (determined from data analysis in Part 1) of SC durvalumab + rHu followed by IV durvalumab at predefined intervals. | Drug: SC durvalumab + rHu Durvalumab + rHu will be administered subcutaneously. Drug: IV durvalumab Durvalumab will be administered intravenously. Other Name: MEDI4736 Drug: Tremelimumab Tremelimumab will be administered to participants with unresectable HCC as an IV infusion. |
