A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab

Sponsor
AstraZeneca
Study ID
NCT07391670
Phase
PHASE1
Status
Recruiting
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Conditions

  • Solid Tumours

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SC durvalumab + rHu — DRUG
    Durvalumab + rHu will be administered subcutaneously.
  • IV durvalumab — DRUG
    Durvalumab will be administered intravenously.
  • Tremelimumab — DRUG
    Tremelimumab will be administered to participants with unresectable HCC as an IV infusion.

Study Details

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).

Key Dates

Start date
Mar 31, 2026
Status verified
May 2026
Primary completion
Aug 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: SC Durvalumab DL1
    Participants will receive DL1 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.
  • Experimental: Part 1: SC Durvalumab DL2
    Participants will receive DL2 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.
  • 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.

Primary Outcome Measure

Area under the concentration-time curve [ Time Frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months). ]

Central Contacts

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