NCT07391670RecruitingPhase 1
A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab.
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 (IMFINZI-subQ)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Jul 2026
Brief summary (registry, in English)
To characterise the PK profile of SC durvalumab.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 4 (estimated)
- First submitted
- 19 Nov 2025
- Start date
- 20 Apr 2026
- Lead sponsor
- AstraZeneca AB
- EU CT number
- 2025-521639-34-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 4
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior exposure to immune checkpoint inhibitors.
Other illness
- Active autoimmune disease requiring systemic treatment.
- Uncontrolled infection (including HIV, hepatitis B or C).
- HCC: Hepatic encephalopathy, uncontrolled ascites, active gastrointestinal bleeding.
- NSCLC: Active pneumonitis or interstitial lung disease requiring systemic therapy.
- LS-SCLC: Extensive-stage disease, uncontrolled CNS metastases.
Other
- Symptomatic brain metastases not controlled by treatment.
Who the study is looking for
- Participant ≥18 years at time of consent.
- ECOG performance status 0 - 1.
- Adequate organ and marrow function at enrolment as defined in the protocol.
- Histologically or cytologically confirmed.
- Locally advanced unresectable Stage III NSCLC (post-definitive chemoradiation, no progression).
- Unresectable hepatocellular carcinoma (BCLC stage B or C, Child-Pugh A, no prior systemic therapy).
- Limited-stage small cell lung cancer (post-definitive chemoradiation, no progression).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Coordinator of this site? Confirm its status | Brzozów | Poland | Recruiting |
| Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie Coordinator of this site? Confirm its status | Koszalin | Poland | Recruiting |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Recruiting |
| Wojewodzki Szpital im Sw Ojca Pio w Przemyslu Coordinator of this site? Confirm its status | Przemyśl | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.