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IMFINZI-subQSafety and Pharmacokinetics of Subcutaneous Durvalumab in Adults with Solid Tumours

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Study Aim

This study aims to evaluate the safety and how your body processes a drug called Durvalumab when given under the skin, in adults with solid tumors.

What is being tested

SC durvalumab + rHu

+ IV durvalumab

+ Tremelimumab

Drug
Who is being recruted

Adenocarcinoma+17

+ Bronchial Neoplasms

+ Carcinoma

Over 18 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information Center
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 31, 2026

Actual date on which the first participant was enrolled.

This study is a Phase I trial happening across multiple locations, focusing on the treatment of solid tumors in adults. The study has two parts: Dose Escalation and Dose Expansion. The first part involves patients with specific types of cancer, including non-small cell lung cancer, hepatocellular carcinoma, or limited-stage small cell lung cancer. This part will test two planned dose levels of a drug called Durvalumab, given subcutaneously (under the skin). The main goal is to understand how this drug behaves in the body and evaluate its safety. The second part of the study will include patients with unresectable hepatocellular carcinoma, and will begin once a suitable dose has been identified from the first part. During the study, participants will receive Durvalumab through subcutaneous injections. The study measures the results by looking at two primary outcomes: the area under the concentration-time curve (AUC) and the observed lowest concentration before the next dose is administered (Ctrough). These measurements help researchers understand how Durvalumab is processed by the body over time and between doses. This information is crucial to determine the appropriate dosing and administration for future use.

Official TitleA Phase I, Multicentre, Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab in Adult Participants With Solid Tumours
NCT07391670
Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information Center
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaBronchial NeoplasmsCarcinomaCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungDigestive System DiseasesDigestive System NeoplasmsCarcinoma, HepatocellularLiver DiseasesLiver NeoplasmsLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsSmall Cell Lung Carcinoma

Criteria

15 inclusion criteria required to participate
Have not progressed following definitive concurrent chemoradiation.

Must not be eligible for locoregional therapy for unresectable HCC.

Histological or cytological documented evidence of NSCLC (locally advanced, unresectable, Stage III).

Histologically or cytologically documented LS-SCLC (Stage I-III).

Show More Criteria

11 exclusion criteria prevent from participating
Mixed SCLC and NSCLC histology.

Prior exposure to immune checkpoint inhibitors.

History of Grade ≥ 2 pneumonitis.

Uncontrolled infection (including human immunodeficiency virus [HIV], hepatitis B or C).

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive DL1 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.

Group II

Experimental
Participants will receive DL2 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.

Group III

Experimental
Participants will receive dose level X (determined from data analysis in Part 1) of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 19 locations

Suspended

Research Site

Fitzroy, AustraliaOpen Research Site in Google Maps
Suspended

Research Site

St Albans, Australia
Suspended

Research Site

Woolloongabba, Australia
Suspended

Research Site

Batumi, Georgia
Recruiting soon19 Study Centers