Could a simple shot replace IV drips for this cancer drug?
NCT ID NCT07391670
First seen Jun 24, 2026 · Last updated Aug 26, 2026 · Updated 6 times
Summary
This early-stage trial is testing whether giving durvalumab as a shot under the skin works as well as the standard IV infusion. About 40 adults with various solid tumours will receive the injection, and researchers will measure drug levels in the blood and watch for side effects. If successful, it could make treatment faster and more convenient.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- durvalumab (an immunotherapy drug) given as a shot under the skin
- What this could lead to
- If it works, this could offer a faster, more convenient way to give durvalumab without needing an IV line.
- What could go wrong
- This is a very early phase 1 trial with only 40 people, so it is not yet clear if the shot works as well as the IV version. Side effects from the injection or the drug itself are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
19 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Research Site
NOT_YET_RECRUITINGFitzroy, 3065, Australia
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Research Site
NOT_YET_RECRUITINGSt Albans, 3021, Australia
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Research Site
NOT_YET_RECRUITINGWoolloongabba, 4102, Australia
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Research Site
RECRUITINGBatumi, 6010, Georgia
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Research Site
RECRUITINGTbilisi, 0112, Georgia
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Research Site
RECRUITINGTbilisi, 0114, Georgia
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Research Site
RECRUITINGBrzozów, 36-200, Poland
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Research Site
RECRUITINGKoszalin, 75-581, Poland
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Research Site
RECRUITINGLublin, 20-090, Poland
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Research Site
RECRUITINGOlsztyn, 10-357, Poland
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Research Site
RECRUITINGPrzemyśl, 37-700, Poland
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Research Site
RECRUITINGSeongnam-si, 13620, South Korea
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Research Site
RECRUITINGSeoul, 03722, South Korea
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Research Site
RECRUITINGSeoul, 06351, South Korea
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Research Site
RECRUITINGSeoul, 5505, South Korea
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Research Site
RECRUITINGTainan, 73657, Taiwan
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Research Site
RECRUITINGTaipei, 110, Taiwan
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Research Site
NOT_YET_RECRUITINGTaipei, 112, Taiwan
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Research Site
NOT_YET_RECRUITINGTaoyuan, 333, Taiwan
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Other studies related to the condition(s) this trial covers.
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- Can a new drug rally the immune system against Hard-to-Treat cancers?
- New drug GEN1119 aims to fight solid tumors that resist standard care
- New drug combo targets Hard-to-Treat cancers in early trial
- Lower dose of olanzapine may ease chemo nausea with less drowsiness
- New drug combo shows promise in controlling Hard-to-Treat cancers