A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab

Recruiting now · Phase 1

Conditions studied: Solid Tumours

In brief

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).

Key facts

Study ID

NCT07391670

Run by

AstraZeneca

People needed

40

Starts

2026-03-31

Expected to finish

2027-08-30

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

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 -
• 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.

Where it is running

• Research Site — Seoul, South Korea (enrolling)
• Research Site — Seoul, South Korea (enrolling)
• Research Site — Tainan, Taiwan (enrolling)
• Research Site — Taipei, Taiwan (enrolling)
• Research Site — Tbilisi, Georgia (enrolling)
• Research Site — Tbilisi, Georgia (enrolling)
• Research Site — Brzozów, Poland (enrolling)
• Research Site — Batumi, Georgia (enrolling)
• Research Site — Lublin, Poland (enrolling)
• Research Site — Olsztyn, Poland (enrolling)
• Research Site — Przemyśl, Poland (enrolling)
• Research Site — Seongnam-si, South Korea (enrolling)
• Research Site — Seoul, South Korea (enrolling)
• Research Site — Taoyuan, Taiwan
• Research Site — St Albans, Australia
• Research Site — Woolloongabba, Australia
• Research Site — Koszalin, Poland
• Research Site — Taipei, Taiwan
• Research Site — Fitzroy, Australia

Full record on ClinicalTrials.gov

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