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Could a simple shot replace IV drips for this cancer drug?

NCT ID NCT07391670

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    19 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Research Site

    NOT_YET_RECRUITING

    Fitzroy, 3065, Australia

  • Research Site

    NOT_YET_RECRUITING

    St Albans, 3021, Australia

  • Research Site

    NOT_YET_RECRUITING

    Woolloongabba, 4102, Australia

  • Research Site

    RECRUITING

    Batumi, 6010, Georgia

  • Research Site

    RECRUITING

    Tbilisi, 0112, Georgia

  • Research Site

    RECRUITING

    Tbilisi, 0114, Georgia

  • Research Site

    RECRUITING

    Brzozów, 36-200, Poland

  • Research Site

    RECRUITING

    Koszalin, 75-581, Poland

  • Research Site

    RECRUITING

    Lublin, 20-090, Poland

  • Research Site

    RECRUITING

    Olsztyn, 10-357, Poland

  • Research Site

    RECRUITING

    Przemyśl, 37-700, Poland

  • Research Site

    RECRUITING

    Seongnam-si, 13620, South Korea

  • Research Site

    RECRUITING

    Seoul, 03722, South Korea

  • Research Site

    RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    RECRUITING

    Seoul, 5505, South Korea

  • Research Site

    RECRUITING

    Tainan, 73657, Taiwan

  • Research Site

    RECRUITING

    Taipei, 110, Taiwan

  • Research Site

    NOT_YET_RECRUITING

    Taipei, 112, Taiwan

  • Research Site

    NOT_YET_RECRUITING

    Taoyuan, 333, Taiwan

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