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
- Seongnam-si and Seoul, South KoreaSee the 2 sites
- Phase
- Phase 1
Where in South Korea
- Seongnam-siSeongnam-si, South KoreaTaking people
- SeoulSeoul, South KoreaTaking people
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?
Trial 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.