Durvalumab given under the skin in adults with solid tumours
Tests durvalumab injected under the skin in adults with solid tumours.
Plain-language title generated from the registry record
Registry title: A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab
Key facts
- Where
- Fitzroy, St Albans, and Woolloongabba, AustraliaSee the 3 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with certain solid tumours: stage III lung cancer that cannot be removed by surgery, limited-stage small cell lung cancer, or liver cancer that cannot be removed by surgery. It tests durvalumab given under the skin.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Lung cancer (non-small cell) stage III that cannot be removed by surgery; small cell lung cancer, limited stage (stage I-III); liver cancer (hepatocellular carcinoma) that cannot be removed by surgery, Child-Pugh class A, with measurable disease
- Earlier treatment
- Lung cancer groups: at least 2 cycles of platinum-based chemotherapy together with definitive radiation therapy (4 cycles of chemotherapy with radiotherapy for small cell lung cancer), and no progression afterwards. Liver cancer: no earlier systemic therapy. No earlier immune checkpoint inhibitors.
Main reasons for not taking part
- Autoimmune disease that needed or needs treatment with the whole body
- Uncontrolled infection, including HIV, hepatitis B or C
- Earlier treatment with immune checkpoint inhibitors
- Mixed small cell and non-small cell lung cancer; active pneumonitis or interstitial lung disease needing systemic therapy
- Liver cancer: hepatic encephalopathy, uncontrolled ascites, or active gastrointestinal bleeding
Read by machine on 9 November 2026.
Where in Australia
- FitzroyHospital not named in the registryNo longer taking part
- St AlbansHospital not named in the registryNo longer taking part
- WoolloongabbaHospital not named in the registryNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07391670EU 2025-521639-34-00
- Record updated
- 24 September 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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; Have not progressed following definitive concurrent chemoradiation; LS-SCLC Participants -; Histologically or cytologically documented LS-SCLC (Stage I-III); Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to enrolment; Have not progressed following definitive concurrent chemoradiation; Part 1 and 2:; Unresectable HCC Participants -; Unresectable HCC based on histopathological confirmation; No prior systemic therapy for unresectable HCC; Must not be eligible for locoregional therapy for unresectable HCC; Child-Pugh Score class A; Measurable disease as defined by RECIST v1.1.
Exclusion: Active or prior documented autoimmune disease requiring systemic treatment; Prior exposure to immune checkpoint inhibitors; Part 1 only:; Locally Advanced Unresectable (Stage III) NSCLC Participants -; Uncontrolled infection (including human immunodeficiency virus [HIV], hepatitis B or C); Active pneumonitis or interstitial lung disease requiring systemic therapy; LS SCLC Participants -; Extensive-stage disease; History of Grade ≥ 2 pneumonitis; Part 1 and 2:; Unresectable HCC Participants -; Active gastrointestinal (GI) bleeding; Mixed SCLC and NSCLC histology; Mixed SCLC and NSCLC histology; Hepatic encephalopathy; Uncontrolled ascites.