RecruitingSolid Tumours
A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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).
Sponsor: AstraZeneca
You may qualify if…
- ✓ An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- ✓ Life expectancy of ≥ 12 weeks at enrolment.
- ✓ Adequate organ and marrow function.
- ✓ Minimum body weight \> 30 kg.
- ✓ Part 1 only:
- ✓ Locally Advanced Unresectable (Stage III) NSCLC Participants -
- ✓ Histological or cytological documented evidence of NSCLC (locally advanced, unresectable, Stage III).
- ✓ Must have received at least 2 cycles of platinum-based chemotherapy concurrent with definitive radiation therapy.
You may not qualify if…
- ✕ Active or prior documented autoimmune disease requiring systemic treatment.
- ✕ Uncontrolled infection (including human immunodeficiency virus \[HIV\], hepatitis B or C).
- ✕ Prior exposure to immune checkpoint inhibitors.
- ✕ Part 1 only:
- ✕ Locally Advanced Unresectable (Stage III) NSCLC Participants -
- ✕ Mixed SCLC and NSCLC histology.
- ✕ Active pneumonitis or interstitial lung disease requiring systemic therapy.
- ✕ LS SCLC Participants -
Source: ClinicalTrials.gov · NCT07391670 · last updated 2026-06-15