RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT07391670

Registry updated: 2026-09-24

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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).

Interventions

SC durvalumab + rHu (Drug)
Durvalumab + rHu will be administered subcutaneously.
IV durvalumab (Drug)
Durvalumab will be administered intravenously.
Tremelimumab (Drug)
Tremelimumab will be administered to participants with unresectable HCC as an IV infusion.

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.

Conditions

Solid Tumours

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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