A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab
Trial Parameters
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Brief Summary
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).
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 ther