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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under the concentration-time curve
Timeframe: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
2
Observed lowest concentration before the next dose is administered (Ctrough)
Timeframe: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).