ARTEMIDE-subQ
Research type
Research Study
Full title
A Phase I, Multicenter, Dose Finding and Dose Confirmation Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Rilvegostomig in Adult Participants with Advanced Solid Tumors Previously Treated with Standard of Care Therapy (ARTEMIDE-subQ)
IRAS ID
1012710
Contact name
Roser Sanz Casañas
Contact email
Sponsor organisation
ASTRAZENECA FARMACÉUTICA SPAIN, S.A
Eudract number
2025-521614-26
Clinicaltrials.gov Identifier
Research summary
The main goal of this study is to find out the right dose of rilvegostomig (hereafter called ‘the study drug’) when given as an injection under the skin, so that it has similar effects to when given directly into the vein.
Participants will come to the study site on specific days for dosing, collection of biosamples (such as blood or urine), and to check on participants to see how they are feeling.
The study is divided into two parts; participants will only take part in one of these parts. Approximately 20 participants will take part in each part.
The study drug is a medication that may help the immune system find and attack cancer cells by blocking certain proteins. Cancer cells can use these proteins to avoid being destroyed by the immune system. By stopping cancer cells from using these molecules, the study drug may help the immune system find and attack cancer cells.
Part 1 focuses on determining the right dose of study drug to be given under the skin. Different doses of study drug will be tested to identify a safe dose that, when given as an injection under the skin, is similar to 750mg of study drug injected into your veins.
Part 2 is aimed at confirming the dose of study drug injected under the skin. Part 2 will begin after a safe dose is found for study drug administration under the skin that is expected to be similar to a 750mg dose given directly into the veins.
In both parts, participants will receive the study drug on the same day every 3 weeks (called a cycle); participants will have up to 35 cycles (105 weeks) in total.
Participants will be in the study for approximately 30 months. About 40 participants will take part in this study.REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0361
Date of REC Opinion
6 Jan 2026
REC opinion
Further Information Favourable Opinion