IMFINZI-subQSafety and Pharmacokinetics of Subcutaneous Durvalumab in Adults with Solid Tumours
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.
SC durvalumab + rHu
+ IV durvalumab
+ Tremelimumab
Adenocarcinoma+17
+ Bronchial Neoplasms
+ Carcinoma
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy 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
Research Site
St Albans, AustraliaResearch Site
Woolloongabba, AustraliaResearch Site
Batumi, Georgia