RecruitingPhase 1NCT07161414

A Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy

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)


Sponsor

AstraZeneca

Enrollment

40 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine the subcutaneous (SC) dose that gives rilvegostomig exposure comparable to the intravenous (IV) exposure, and to evaluate the pharmacokinetics (PK) and safety of SC rilvegostomig in adult participants with advanced solid tumors previously treated with standard of care therapy for whom immunooncology (IO) monotherapy would be deemed appropriate by the investigator.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new way to give a cancer immunotherapy drug called rilvegostomig — by injection under the skin (subcutaneous) rather than through an IV. It is studying how the drug moves through the body and whether this delivery method is safe for people with advanced solid tumors. **You may be eligible if...** - You have an advanced solid tumor (spread or cannot be surgically removed) that has been confirmed by biopsy - You have already received standard cancer treatment - You are in reasonably good physical health and able to carry out daily activities - You weigh at least 30 kg - Your life expectancy is at least 12 weeks - Your organs (kidneys, liver, blood counts) are functioning adequately **You may NOT be eligible if...** - You have had an organ transplant - You have had another primary cancer in the past 2 years - You have serious uncontrolled illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIV Rilvegostomig

Rilvegostomig administered IV.

DRUGRecombinant Human Hyaluronidase (rHu)

rHu administered subcutaneously.

DRUGSC Rilvegostomig

Rilvegostomig administered subcutaneously.

DRUGSC rilvegostomig + rHu

SC rilvegostomig + rHu administered subcutaneously.


Locations(11)

Research Site

Huntersville, North Carolina, United States

Research Site

San Antonio, Texas, United States

Research Site

Fairfax, Virginia, United States

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Barcelona, Spain

Research Site

Barcelona, Spain

Research Site

Madrid, Spain

Research Site

Madrid, Spain

Research Site

Newcastle upon Tyne, United Kingdom

Research Site

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07161414


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