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NCT07391670From ClinicalTrials.govRecruiting

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

  • Solid Tumours

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
AstraZeneca
Enrolment target
40
Started
31 March 2026
Main results due
30 August 2027
Study sites
19
Registry updated
24 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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 -

* Mixed SCLC and NSCLC histology.
* Extensive-stage disease.
* History of Grade ≥ 2 pneumonitis.

Part 1 and 2:

Unresectable HCC Participants -

* Hepatic encephalopathy.
* Uncontrolled ascites.
* Active gastrointestinal (GI) bleeding.

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(19)

  • Research Site

    Fitzroy, Australia

    Withdrawn

  • Research Site

    St Albans, Australia

    Withdrawn

  • Research Site

    Woolloongabba, Australia

    Withdrawn

  • Research Site

    Batumi, Georgia

    Recruiting

  • Research Site

    Tbilisi, Georgia

    Recruiting

  • Research Site

    Tbilisi, Georgia

    Recruiting

  • Research Site

    Brzozów, Poland

    Recruiting

  • Research Site

    Koszalin, Poland

    Recruiting

  • Research Site

    Lublin, Poland

    Recruiting

  • Research Site

    Olsztyn, Poland

    Recruiting

  • Research Site

    Przemyśl, Poland

    Recruiting

  • Research Site

    Seongnam-si, South Korea

    Recruiting

  • Research Site

    Seoul, South Korea

    Recruiting

  • Research Site

    Seoul, South Korea

    Recruiting

  • Research Site

    Seoul, South Korea

    Recruiting

  • Research Site

    Tainan, Taiwan

    Recruiting

  • Research Site

    Taipei, Taiwan

    Recruiting

  • Research Site

    Taipei, Taiwan

    Withdrawn

  • Research Site

    Taoyuan, Taiwan

    Withdrawn

Showing 19 of 19 sites. 14 of the 19 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07391670. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutane | Trialion